Yourlawyer.com (Fusarium Fungus News)

Bausch & Lomb eye infections, lawsuits, surface in Nashville

Tue, 13 Feb 2007 00:00:00 -0800

Two Nashville-area couples have filed separate federal lawsuits against the manufacturer of a contact lens solution that last year was the source of a nationwide health scare and the subject of a national recall.

In early January, John Richardson of Clarksville brought a civil lawsuit against Bausch & Lomb, the maker of the soft contact lens solution “ReNu with MoistureLoc Multi-Purpose Solution,” alleging his use of the solution led directly to his development of “Fusarium Keratitis,” a serious eye condition that can cause permanent vision loss.

Last week, a second similar suit was also filed in U.S. District Court in Nashville on behalf of Kathy Binkley of Nashville. Like Richardson, Binkley claimed her contraction of fusarium keratitis was linked to her use of the ReNu solution.

Although these two lawsuits are the first to hit Middle Tennessee courts, they are far from the first to be levied against Bausch & Lomb, which is facing potentially years worth of litigation as a result of the ReNu with MoistureLoc solution.

In May of last year, Bausch & Lomb removed ReNu with MoistureLoc from the market after the Centers for Disease Control (CDC) linked the solution to the fungal eye infection fusarium keratitis.

After more 100 confirmed cases of the eye fungus were reported, the CDC study found that the fungus likely originated in the company’s Greenville, S.C. plant.

Local experts say the number of known Middle Tennessee cases was in the single digits.

But for Richardson and Binkley, the cases were serious, according to their lawsuits.

Richardson, who was diagnosed with Fusarium Keratitis in February of 2006, underwent a surgical procedure known as a corneal transplant “in an attempt to save his eye and restore some useful vision.”

He has suffered permanent vision loss as a result of his condition and procedure, Richardson’s lawsuit says.

Binkley contracted the fungus in the form of a “Fusarium corneal ulcer” in November 2005, and underwent a penetrating keratoplasty two months later.

Binkley has suffered decreased vision, distorted and blurred vision, eye pain, headaches, light sensitivity and possible permanent vision loss, her lawsuit claims. She is 44 years old, said her attorney.

Dr. Jeffrey Sonsino, an Optometrist at the Vanderbilt Eye Institute, said his hospital has only seen one case of Fusarium Keratitis.

But Sonsino said the CDC study was “pretty compelling” in showing at least a correlation between use of the ReNu with MoistureLoc solution and the fungus.

And Sonsino, who is also the Chair of the Anterior Segment Committee of the Cornea and Contact Lens section of the American Optometric Association, said the condition that many ReNu patients developed is a very serious one.

“Fusarium Keratitis is a very severe ocular condition where a fungus actually invades the cornea. And one of the reasons it is so serious is because it is very difficult to treat,” Sonsino said.

“A very high proportion of the patients who have this kind of infection will end up losing some vision. In fact, one third of the patients who had Fusarium keratitis in this outbreak required a surgical procedure called a corneal transplant,” he continued. “That’s not a simple procedure and it’s one that’s fraught with complications.

“This is a very serious condition,” Sonsino said.

It is perhaps for that reason that a tremendous number of private attorneys have already begun soliciting clients who developed this condition in the hopes of filing a class action lawsuit against Bausch & Lomb.

Currently, the litigants against Bausch & Lomb have not been awarded “class” status.

But the company’s immediate future is already proving to be less than auspicious.

Just last week, the the Associated Press reported that Bausch & Lomb lowered its 2006 revenue forecast, citing a “slower-than-expected recovery” from the ReNu with MoistureLoc recall and “sluggish” contact lens sales.

The good news, Sonsino said, is that with the faulty solution off the shelf, the fungal outbreak has likely vanished.

“It’s pretty conclusive that this outbreak was due to this product,” Sonsino said. “But my best guess is that from a medical standpoint this has blown over since they’ve stopped all the shipments of this product.”

Suits Piling Up in Eye-Fungus Outbreak

Wed, 13 Dec 2006 00:00:00 -0800

The brown iris of Janice McConnell's ravaged left eye has turned pale blue. The vision in Gina Macchia's right eye, with its grossly enlarged pupil, is limited to light and shadows.

Both women underwent eye-saving, cornea-transplant surgery this year. They lost months away from their jobs, wear sunglasses to avoid stares and battle a toxic mix of anger, fatigue and frustration.

"Some days I get a little down, but I cope with it. I hang on to some hope that I'm going to see again out of that eye," said McConnell, 57, a job-program coordinator in Frazer, Pa.

The culprit, a fungal infection so rare that most eye doctors had never seen a case, sent a cold shiver through contact lens wearers around the world. Hundreds of people said they contracted the dangerous microbe while using a new multipurpose lens solution made by Rochester-based Bausch & Lomb Inc.

Consumer lawsuits against Bausch & Lomb have been piling up in U.S. courts, and the debacle could drag down the optical products company's finances for years. Lawyers now expect 500 to 700 people will seek damages for Fusarium keratitis infections in trials beginning as early as next summer.

Lawsuits could wind up costing Bausch & Lomb $1 billion in damages, analyst David Maris of Banc of America Securities estimated. Losing its dominance in the lucrative lens care market 34 million Americans wear contact lenses could prove even more draining.

Already beset by accounting irregularities at its Asian subsidiaries, the company slashed its 2006 profit forecast by 78 percent. Its share of U.S. lens care kits plunged from 31 percent to 8 percent before rebounding to 21 percent in the July-September quarter, according to Health Products Research in Whitehouse, N.J.

Of the 180 infection victims confirmed so far in 35 states, 59 needed cornea transplants, the Centers for Disease Control and Prevention in Atlanta said. At least 120 more lens wearers were stricken with the infection in the fall of 2005 in Hong Kong, Singapore, Malaysia and China, health officials and lawyers in those countries reported. It later appeared in the U.S.

Several people allege the MoistureLoc solution caused them to lose an eye.

"There were days that I thought I was going insane," said Macchia, 49, a financial broker's assistant in Jackson, Mich.

Questions abound over whether Bausch & Lomb reacted quickly enough.

The company stopped selling MoistureLoc in Hong Kong and Singapore in February but only halted U.S. shipments in April. It permanently withdrew the $100-million-a-year product from all markets in mid-May when the Food and Drug Administration called it the "potential root cause."

After months of testing, the company determined that MoistureLoc's unique disinfectant and moisture-retention agents, in combination with poor hygiene habits, could in some cases create a thin film that sheltered the fungus from the solution's sterilizer.

An analysis by leading eye doctors and the CDC concluded that MoistureLoc was the only cleaner implicated, noting the spike in infections rapidly subsided after its worldwide recall.

In the company's view, spokeswoman Barbara Kelley said, the outbreak was caused by various factors including the ingredients in the solution and how the patients used it.

"The issue is, what is that unique combination of factors that led some people to get the infection and others not?" Kelley said.

While Bausch & Lomb said it acted swiftly to unlock a bewildering medical riddle, the timeline is the crux of the legal battle, said Carl Tobias, a law professor at the University of Richmond in Virginia who specializes in product liability disputes.

"What did they know, when did they know it, and did they move quickly enough once they had information that would lead them to believe people were being hurt by the product?" Tobias asked.

McConnell bought a bottle of MoistureLoc in September 2005, thinking its touted moisturizers might solve the drying of her eyes in wintertime. She was at work in mid-November when she suddenly felt a searing pain as if "a piece of sharp glass" was caught under her lens.

The eye turned beet red. She couldn't stand the light. She stayed home with the curtains drawn for nearly two weeks, taking antibiotic drops hourly. The pain got so severe, she was rushed to Wills Eye Hospital in nearby Philadelphia and finally diagnosed with the fungal infection.

By January, "the fungus had broken through the cornea, started eating the eye," McConnell said in a trembling voice. "They dug deep into the eye to get it out."

The invasive transplant surgery created a blinding cataract that was eventually removed in August. But with her vision deteriorating again, she recently found out she'll need a new cornea implant. As for the scarred iris, she said, "I'm at the point, I don't ever care if it turns brown again."

Robbed of depth perception, McConnell drives only on familiar roads but not at night because "headlights are doubled." She's embarrassed by her clumsiness. "I bump into people because I can't focus," she said.

In one case, an Oklahoma teenager whose eye infection disseminated through her bloodstream almost died, said Dr. Arthur Epstein, chairman of the American Optometric Association's contact lens and cornea section. "Some of these patients were terrifically harmed," he said.

In addition, said the CDC's medical epidemiologist, Dr. Benjamin Park, "there were some cases that were so severe that they did require" removal of the eye.

Macchia's attorney, Jason Mark of Parker & Waichman in Great Neck, N.Y., said one client in West Virginia "has to wear a prosthetic shell in her socket because her eye became so deformed from the treatment."

Macchia's cornea operation in March lasted 6 1/2 hours.

The doctors "Roto-Rootered my retina," she said, laughing grimly. "If I keep this cornea, the doctor will fit me with a contact lens as a cosmetic so it'll look like my other eye. That'll probably help. Like I told him, I'll wear anything as long as it's not Bausch & Lomb."

An eye for an eye, literally

Wed, 08 Nov 2006 00:00:00 -0800

This week, Bausch & Lomb received a condemnatory letter from the FDA regarding the manufacturing conditions at one of its plants, where an inspection revealed several quality control problems. The inspection stemmed from an incident this year where one of the company's contact lens solutions, ReNu MoistureLoc, was linked to more than a hundred cases of Fusarium keratitis, a rare and potentially blinding fungal eye infection. The letter condemned manufacturing practices as well as the company's response to the issue.

As a result of the outbreak, several people received cornea transplants to save their eyesight, while many more narrowly escaped the same fate. However, the most troubling aspect of this incident isn't a few cornea transplants - it's that Bausch & Lomb waited several months before doing anything about it. The rise of infections in the United States was preceded by dozens of infections in other countries. Singapore, Malaysia and Hong Kong all reported similar outbreaks in connection with the MoistureLoc product. And surprisingly, months before the product was pulled from the shelves in the United States, it was pulled from the shelves in each of these three countries. Then, after the infections received attention here, Bausch & Lomb decided to halt shipments of the product and recall it entirely.

Would they have pulled the product at all if our country hadn't uncovered the problem? The thought is troubling enough. Three discrete instances of the outbreak weren't sufficient to warrant this action, so it's no stretch to imagine that similar outbreaks would have occurred in other countries without our intervention.

Luckily for those affected, there is a way to seek justice. And as much as we love to bash lawyers in this country, they're the people delivering it. The number of lawsuits prompted by this incident will provide enough punishment so that this company and others will rethink their crisis response strategies. We can only hope that if Bausch & Lomb was responsible, then the litigants who lost their eyesight or nearly did take this company to the bank.

FDA warns Bausch & Lomb on contact lens solution linked to infections

Tue, 07 Nov 2006 00:00:00 -0800

Bausch & Lomb Inc. failed to formally report nearly three dozen foreign cases of fungal eye infections later linked to one of its contact lens solutions, according to a federal warning letter.

Bausch & Lomb didn’t report the 35 serious injury reports by April 7, as required by law, after Singapore health officials had alerted the Rochester, N.Y. company, the Food and Drug Administration said in the letter. The reporting failure occurred after the company had suspended sales of its ReNu with MoistureLoc solution in Singapore.

It also came after the FDA had begun an investigation of the Greenville, S.C. manufacturing plant where Bausch & Lomb made the now-withdrawn MoistureLoc solution.

Bausch suspended sales of MoistureLoc in Singapore and Hong Kong in February and U.S. sales in April. It initiated a global recall in May. The company later acknowledged the brand of solution was the potential “root cause” of increased risk of the fungal infection, called Fusarium keratitis.

Ultimately, health official reported several hundred cases of Fusarium keratitis in parts of Asia and the United States.

The FDA warning letter refers in part to the inadequacy of a previous company response to FDA concerns about its reporting of the Singapore cases.

“Your response states that this information did not reasonably suggest that the ReNu with MoistureLoc multi-purpose solution device caused or contributed to the Fusarium infections. FDA disagrees. This information suggested that your ReNu product may have caused or contributed to the event,” the letter reads in part.

In a statement, Bausch said it has completed more than two-thirds of the corrective actions it pledged in response to the FDA’s concerns. The issues stem from the March-to-May inspections of the Greenville, S.C. plant. Bausch said it should be ready for a reinspection before March 31.

The 11-page letter, redacted in parts, largely details previously disclosed manufacturing problems at the plant. The FDA said it found no problems at the plant with any other company products.

Bausch & Lomb Receives FDA Warning Letter related to Inspection at Greenville, S.C. Solutions Manufacturing Plant conducted in March-May 2006

Mon, 06 Nov 2006 00:00:00 -0800

Bausch & Lomb (NYSE: BOL) today announced that it has received a Warning Letter from the United States Food and Drug Administration relating to an inspection the agency conducted at the Company’s Greenville, S.C. solutions manufacturing plant during the period March 22 through May 15, 2006 in connection with reports of Fusarium keratitis from some users of ReNu with MoistureLoc solution produced in the facility.

Although the inspection did not identify any conditions at the manufacturing facility that contributed to or caused the reported adverse events, it identified some important issues that the Company is addressing through a series of corrective actions. The Warning Letter contains no new observations, but rather documents those corrective actions still in process. Bausch & Lomb voluntarily initiated a global recall of its ReNu with MoistureLoc lens care solution on May 15, 2006.

In response to the FDA’s report on the inspection observations (FDA Form 483), the Company immediately initiated a series of corrective actions and submitted a comprehensive plan summarizing those actions on June 30, 2006. The Warning Letter summarizes the agency’s assessment of the corrective actions completed as of the Company’s June 30, 2006 response. Since that time, the Company has continued to keep the FDA updated on its progress toward completing the corrective actions outlined in its response to the Form 483.

At an update with agency representatives in mid-August, the Company reported having completed more than half of the action items. In a report submitted on October 12, which the agency has yet to finish reviewing, the Company reported that more than two-thirds of the action items had been completed; that the majority of the outstanding items were in the process of implementation according to schedule; and that a handful had been assigned new completion dates. Of the unfinished actions itemized in the Warning Letter, the great majority were reported as complete in the October 12 update, although, of course, they cannot be considered closed until the FDA has had the opportunity to review or inspect them.

Bausch & Lomb said today that it has taken very seriously its responsibility to respond with appropriate speed and thoroughness to the FDA’s observations. The Company has confidence in the products it manufactures at the facility based on the processes and systems in place. Bausch & Lomb is committed to completing the remainder of the action items in its corrective plan according to schedule, and expects to be ready for a re-inspection in the first quarter of 2007.

FDA: Bausch & Lomb failed on reporting

Mon, 06 Nov 2006 00:00:00 -0800

Bausch & Lomb Inc. failed to formally report nearly three dozen foreign cases of fungal eye infections later linked to one of its contact lens solutions, according to a federal warning letter.

Bausch & Lomb didn't report the 35 serious injury reports by April 7, as required by law, after Singapore health officials had alerted the Rochester, N.Y. company, the Food and Drug Administration said in the letter. The reporting failure occurred after the company had suspended sales of its ReNu with MoistureLoc solution in Singapore.

It also came after the FDA had begun an investigation of the Greenville, S.C. manufacturing plant where Bausch & Lomb made the now-withdrawn MoistureLoc solution.

Bausch suspended sales of MoistureLoc in Singapore and Hong Kong in February and U.S. sales in April. It initiated a global recall in May. The company later acknowledged the brand of solution was the potential "root cause" of increased risk of the fungal infection, called Fusarium keratitis.

Ultimately, health official reported several hundred cases of Fusarium keratitis in parts of Asia and the United States.

The FDA warning letter refers in part to the inadequacy of a previous company response to FDA concerns about its reporting of the Singapore cases.

"Your response states that this information did not reasonably suggest that the ReNu with MoistureLoc multi-purpose solution device caused or contributed to the Fusarium infections. FDA disagrees. This information suggested that your ReNu product may have caused or contributed to the event," the letter reads in part.

In a statement, Bausch said it has completed more than two-thirds of the corrective actions it pledged in response to the FDA's concerns. The issues stem from the March-to-May inspections of the Greenville, S.C. plant. Bausch said it should be ready for a reinspection before March 31.

The 11-page letter, redacted in parts, largely details previously disclosed manufacturing problems at the plant. The FDA said it found no problems at the plant with any other company products.

FDA to B&L: Fix violations at lens solution plant

Mon, 06 Nov 2006 00:00:00 -0800

Bausch & Lomb Inc. said today it has received a warning from federal regulators about its response to an inspection of a manufacturing plant involved in the investigation of an outbreak of a rare eye infection in contact lens wearers.

In an 11-page letter to B&L dated Oct. 31, the Federal Drug Administration outlines a series of violations at the company’s Greenville, S.C. plant that it feels have not yet been adequately addressed. The alleged violations include a range of operating practices, including record keeping, cleanliness, inspection and environmental control.

If the violations are not addressed, according to the letter, B&L could face a range of sanctions, including a fine or delays in regulatory approvals of “reasonably related” products. The FDA also said that other federal agencies are advised of the warning letters to evaluate when awarding contracts.

The affected plant made ReNu with MoistureLoc, a contact lens solution tied to reports of Fusarium keratitis involving contact lens wearers in the United States and several foreign countries.

The FDA’s inspection did not link any conditions at the plant to the outbreak of Fusarium, but it did order corrective actions in record-keeping and other operating conditions.

A related investigation by the Centers for Disease Control concluded that ReNu with MoistureLoc was probably not contaminated during the manufacturing process. Instead, the CDC said it was likely the solution has “unique properties” that may have triggered the outbreak. B&L recalled MoistureLoc worldwide earlier in May.

The CDC’s report was based on a controlled study following reports of 164 confirmed cases of Fusarium infections in 33 states and one U.S. territory. Almost 60 percent of the patients reported using ReNu with MoistureLoc.

The outbreak has hovered over B&L for several months. The company earlier this year projected that pre-tax earnings for 2006 would probably be about $80 million, down from initial forecasts. B&L cited costs of the recall and related brand-rebuilding efforts.

In a release today, B&L said the FDA letter contains no new observations; rather, the company says it summarizes the agency’s assessment of B&L’s progress as of June 30.

At an update in mid-August, B&L reported to the FDA it had completed more than half the action items, the company said in its release. That number had increased to two-thirds by early last month, B&L also said, with the remaining items either in process of implementation or assigned new completion dates.

“Of the unfinished actions itemized in the warning letter, the great majority were reported as complete in the Oct. 12 update,” B&L said in its release. Those items cannot be considered closed until the FDA has had an opportunity to review or inspect them, B&L said.

Bausch & Lomb Receives Warning from FDA over Handling of ReNu with MoistureLoc

Mon, 06 Nov 2006 00:00:00 -0800

In a press release this morning, Rochester, New York-based Bausch & Lomb calls itself “the eye health Company, dedicated to perfecting vision and enhancing life for consumers around the world.” However, regulators at the U.S. Food and Drug Administration may not agree. Last week, the FDA sent a rather incriminating warning letter to the company, chastising them for neglecting to report nearly three dozen cases of severe fungal eye infections connected to its ReNu with MoistureLoc contact lens solution.

The letter also cited numerous violations stemming from a two-month investigation of Bausch’s Greenville, South Carolina, facility this past spring. Referring to Bausch’s contact lens solutions, the FDA said that “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements.”

According to the October 31 warning letter, the company failed to inform the FDA of “35 serious injury reports of Fusarium keratitis from Singapore’s Minister of Health in February 2006 relating to ReNu with MoistureLoc Multi-Purpose Solution. None of the complaints were reported to the Agency as of April 7, 2006,” as required by law.

The company suspended Asian sales of ReNu with MoistureLoc in February and U.S. sales in April before eventually issuing a global recall on May 15. The spring FDA inspection did not directly connect any of the violations with the spread of Fusarium keratitis. However, the letter claimed that Bausch failed to thoroughly investigate the issues related to Fusarium keratitis. Bausch “did not include sterility or biocidal testing for ReNu with MoistureLoc Multi-Purpose Solution product lots implicated in complaints received from Hong Kong” and “had not performed sterility testing on the returned/retain samples in conjunction with the Fusarium investigation for complaints received from Malaysia and Singapore.”

Bausch has 15 days from the date of the letter to respond to the allegations. “Failure to promptly correct these violations,” says the FDA, “may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.”

Recalled ReNu Lens Solution Still on the Market

Tue, 24 Oct 2006 00:00:00 -0700

The recalled contact-lens solution ReNu with MoistureLoc had maintained a 2 percent market share into the early weeks of September, despite the fact that distribution of the Bausch and Lomb product was halted by the company on April 9. Use of that solution has been connected to a serious fungal condition known as Fusarium keratitis, but recent market data call into question whether or not the company has been aggressive and diligent enough in alerting retailers, patients, and medical professionals to the product’s potential dangers.

In their announcement of Bausch and Lomb’s decision in April, the FDA said that the company was “voluntarily stopping shipment of the ReNu MoistureLoc product while they are continuing to investigate the cause of these infections. Soft contact lens users who have existing supplies of the Renu Moisture Loc should use the product with caution and report any signs and symptoms of eye infection to their doctors.” The following week, the company issued what they called a “voluntary market withdrawal,” which requested that retailers temporarily suspend sales while research was ongoing.

It wasn’t until the following month that Bausch and Lomb announced a permanent withdrawal of the product from shelves, in the face of mounting evidence that the product carried the significant risk of Fusarium keratitis, which can cause permanent damage including blindness. This permanent recall came only after the Centers for Disease Control had confirmed more than 100 cases of the condition around the country. In more than two thirds of those cases involving contact-lens users, the sufferer had used ReNu with MoistureLoc.

Bausch and Lomb has encountered a great deal of criticism for their handling of the situation. Many researchers allege that the company had reason for concern about the product’s safety well before they announced any action in April. Many critics believe that the company had been alerted by medical officials in Hong Kong about the potentially dangerous side effects as far back as November of 2005.

In addition, the company has failed to do enough to inform users and doctors of the risks involved. Observers have found that the product can still be found on the shelves of some retail outlets, perhaps indicating that Bausch and Lomb hasn’t adequately reached out to its retailers to inform them of the recall.

Clarifying the View of Contact Lens Care

Tue, 05 Sep 2006 00:00:00 -0700

In May 2006, Bausch and Lomb recalled their Renu eye contact solution in the United States. Shortly thereafter they also did so in Hong Kong and Singapore. There wasn't much fan-fare surrounding the recall, it was just one of those things that surfaced in the news for a day or two and was immediately dismissed.

Recently however, Bausch and Lomb have entered the news again. The news headlines are quite attention grabbing: "Contact Lens solution eyed in fungus outbreak"; "The eye fungus among us thanks to MoistureLoc"; "Bausch and Lomb issues Renu contact lens solution doctor advisory".

As contact lens users here can confirm, buying contact lens solution in Ukraine can be a bit of a challenge. Only certain pharmacies and official optical shops sell solution, usually at higher prices than we are used to paying elsewhere. Also, Bausch and Lomb seem to have something akin to a monopoly in Kyiv. In fact, I have yet to see another brand of contact lens solution on display. Bausch and Lomb's Renu solution is considered one of the top brands of lens solution, so up until recent events, such a monopoly has been the least of our eye care worries. Now the situation seems less clear.

It turns out a naturally occurring fungus named fusarium, usually only found in plants and soil, has formed an alliance with one of the components in Renu multipurpose contact solution with MoistureLoc. The result is an eye fungus that can lead to blindness (or a necessity of cornea transplants) if not treated quickly. Symptoms of the eye fungus include blurry vision, pain or redness, increased sensitivity to light and excessive discharge from the eye, but it is not transmitted from person to person.

Interestingly, this eye fungus only occurs in users of contact solution with MoistureLoc. People who use Renu multipurpose contact solution without the MoistureLoc component are unaffected. Bausch and Lomb is still trying to determine why and how the fungus is interacting with the contact solution that contains 'MoistureLoc', but in the meantime has advised contact lens wearers to use the solution without it.

This is easier said than done around here. I went searching for Renu contact solution without MoistureLoc and found that most places are still selling the solution with the additive in question. I finally located plain multipurpose solution in a state pharmacy, and promptly bought a bottle and began to use it instead of my potentially fungus inducing MoisureLoc one. If you choose to continue using the bottle you have, I recommend being more vigilant about lens hygiene than usual and if you start to develop any of the above mentioned symptoms, get medical help immediately. Many things can be replaced, but eyesight is not one of them.

ReNu with MoistureLoc Still Sold in Ukraine

Tue, 05 Sep 2006 00:00:00 -0700

According to the Ukrainian Observer, bottles of ReNu with MoistureLoc contact lens solution are still on the shelves of drugstores in the Ukraine. ReNu with Moisutreloc was removed from most major markets earlier this year after the solution was linked to fusarium keratitis, a serious fungal infection that can cause blindness. In the United States, hundreds of lawsuits have been filed against Bausch & Lomb on behalf of users of ReNu with Moistureloc that developed serious eye infections.

Last month, the CDC issued the results of a study that found that ReNu with MoistureLoc lacked the necessary sterilization qualities to prevent eye infections with normal lens use. The report found that the outbreak of Fusarium keratitis was directly associated with the use of ReNu with MoistureLoc, and that the unique properties of the solution may have contributed to the outbreak of fungal infections. The CDC study also found that suboptimal hygiene practice appeared unlikely to contribute to the outbreak, and that biofilm on the contact lenses or contact lens cases may have played a role in causing the spread of Fusarium keratitis.

Fusarium keratitis is a severe fungal infection of the cornea that can result in permanent blindness. First-line treatment includes topical and oral antifungal medications; patients who do not respond to these treatments usually require surgical intervention, including corneal transplant. While Fusarium keratitis has been primarily linked to ReNu with MoistureLoc, many doctors and researchers believe that all multi-purpose contact lens solutions may be associated with dangerous infections.

Parker & Waichman, LLP Commends JAMA Study On ReNu With MoistureLoc

Thu, 31 Aug 2006 00:00:00 -0700

Parker & Waichman, LLP, announced that despite the limitations of the study, it agrees with the major findings detailed in the CDC report on ReNu with MoistureLoc that was published on August 23, 2006 in the Journal of the American Medical Association (JAMA). Parker & Waichman, LLP is a leader in the global litigation against Bausch & Lomb, Inc. (NYSE:BOL) on behalf of people injured by the recalled contact lens solution, and had numerous cases pending against Bausch & Lomb in state and federal courts throughout the country. For more information on ReNu with MoistureLoc(tm) please visit http://www.yourlawyer.com/topics/overview/renu_contact_solution or http://www.renulawsuit.com.

Parker & Waichman, LLP believes the following findings in the CDC report establish that ReNu with MoistureLoc lacks the necessary sterilization qualities to prevent eye infections with normal lens use.

The outbreak of Fusarium keratitis was associated with the use of ReNu with MoistureLoc
The unique properties of ReNu with MoistureLoc formula may have contributed to the outbreak of fungal infections
The Fusarium keratitis was likely caused as a result of extrinsic contamination of the contact lens solution bottle or contact lens cases outside the manufacturing or storage process
Suboptimal hygiene practice appeared unlikely to contribute to the outbreak
Biofilm on the contact lenses or contact lens cases may have played a role in the outbreak
Some hygiene practices may have facilitated the growth of biofilms
Fusarium may have specific qualities promoting adherence and penetration into the contact lenses that allow survival within contact lens cases when used with ReNu with MoistureLoc

Parker & Waichman, LLP believes the CDC report did not go far enough as to some of above areas.

The report also indicated that the first report of Fusarium keratitis in the United States was made by Dr. David S. Chu, a New Jersey ophthalmologist and a specialist in cornea diseases on March 8, 2006. This contradicts what Dr. Levy, the Chief Medical Officer of Bausch & Lomb, told the Rochester Democrat Chronicle in their April 21, 2006. In this story Dr. Levy claimed that Bausch & Lomb was the first to notify the CDC of Dr. Chu's report to them. This revelation appears to demonstrate that Bausch & Lomb knew about the association of ReNu with MoistureLoc's link with Fusarium keratitis in the United States at least a month and a half before they notified any regulatory or health agency. This, on top of the notice that Bausch & Lomb had from Asia regarding the association of ReNu with MoistureLoc with Fusarium keratitis is very significant.

Fusarium keratitis is a severe infection of the cornea. Risk factors for infection usually include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiencies, and, rarely, contact lens use. An estimated 30 million persons in the United States wear soft contact lenses; the annual incidence of microbial keratitis is estimated to be 4-21 per 10,000 soft contact lens users. Fusarium keratitis is more prevalent in warm climates. First-line treatment includes topical and oral antifungal medications; patients who do not respond to these treatments usually require surgical intervention, including corneal transplantation. These fungal infections are not transmitted from person to person.

In addition, Parker & Waichman has received thousands of inquiries from contact lens wearers who have contracted other types of microbial keratitis including bacterial, acanthamoeba and viral keratitis from other Bausch & Lomb multipurpose contact lens solutions as well as from multipurpose contact lens solutions from other manufacturers.

As the accompanying commentary to the CDC report in the August 23rd edition of JAMA noted, "The broader question that deserves further attention is whether multipurpose contact lens solutions although more convenient to use, are less effective against fungi than lens care systems that use a separate disinfection solution, such as hydrogen peroxide." We think that statement, while enlightening, needed to include the other forms of microbial keratitis.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. Parker & Waichman, LLP was the first law firm nationwide to file a class action on behalf of victims of ReNu with MoistureLoc. The class action seeks, among other remedies, a medical monitoring fund to enable consumers to obtain medical screening and treatment services. In addition to ReNu with MoistureLoc, Parker & Waichman, LLP is currently representing victims of Guidant Defibrillators, Zyprexa, Ortho Evra Patch, Ketek, Tequin, Fosamax, DES, Mirapex and other defective medications and medical devices. For more information on Parker & Waichman, LLP please visit: http://www.yourlawyer.com or call (800) LAW-INFO ((800) 529-4636).

CONTACT: Parker & Waichman, LLP
          Jason Mark, Esq.
          Melanie H. Muhlstock, Esq.
          (800) LAW-INFO
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Bausch & Lomb ReNu with MoistureLoc Recall History

Mon, 28 Aug 2006 00:00:00 -0700

ReNu with MoistureLoc was removed from the market after the CDC discovered numberous cases of fusarium keratitis were linked to the product. The recall has slowed the outbreak of the fungal eye infection but it is estimated that MoistureLoc still holds over 2 percent of the market, because many people are still unaware that the solution has been recalled. Below is a detailed timeline of Bausch Lomb’s ReNu with MoistureLoc.

May 5, 2003 – Bausch & Lomb filed a Summary 510(k) (K031646) for a product they called “Bausch & Lomb Multi-Purpose Solution NRC03”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution”. Under “Predicate Devices”, Bausch & Lomb describe the solution:

Description of the Device Bausch & Lomb Multi-Purpose Solution NRC03 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranatee (hydroxyalkylphosphonate), poloxamer 407, polyquatemnium- 10, poloxamine 1107, purified water and preserved with polyaminopropyl biguanide (0.0001 %). (emphasis added)
May 5, 2003 – Bausch & Lomb filed a Summary 510(k) (K031646) for a product they called “Bausch & Lomb Multi-Purpose Solution NRC03”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution”. Under “Predicate Devices”, Bausch & Lomb describe the solution: Description of the DeviceBausch & Lomb Multi-Purpose Solution NRC03 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranatee (hydroxyalkylphosphonate), poloxamer 407, polyquatemnium- 10, poloxamine 1107, purified water and preserved with polyaminopropyl biguanide (0.0001 %). (emphasis added)Note: This is a Multi-Purpose Solution that is essential the same as ReNu with MoistureLoc, accept it uses PHMB as a disinfectant.

May 5, 2003 – Bausch & Lomb filed a Summary 510(k) (K031646) for a product they called “Bausch & Lomb Multi-Purpose Solution NRC03”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution”. Under “Predicate Devices”, Bausch & Lomb describe the solution: Description of the Device Bausch & Lomb Multi-Purpose Solution NRC03 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranatee (hydroxyalkylphosphonate), poloxamer 407, polyquatemnium- 10, poloxamine 1107, purified water and preserved with polyaminopropyl biguanide (0.0001 %). (emphasis added)Note: This is a Multi-Purpose Solution that is essential the same as with MoistureLoc, accept it uses PHMB as a disinfectant. December 11, 2003 – Bausch & Lomb filed a Summary 510(k) (K033854) for a product they called “Bausch & Lomb Multi-Purpose Solution NRC07”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution” and “Bausch & Lomb Multi-Purpose Solution NRC03”. Under “Predicate Devices”, Bausch & Lomb describe the solution:

Description of the Device

Bausch & Lomb Multi-Purpose Solution NRC07 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranatee (hydroxyalkylphosphonate), poloxamer 407, polyquatemnium- 10, poloxamine 1107, purified water and preserved with Alexidine dihydrochloride (0.00045%). (emphasis added)

NOTE: 2 observations regarding the May 5 and December 11, 2003 entries. They are the identical product except for the preservative used. Except that the preservative used in the May 5th filing was PHMB, and the preservative used in the December 11th filing was alexidine. Both 510(k)’s were filed using the incorrect “Proprietary Name” which should have been the name of the product intended to be used in marketing.

December 14, 2003 – The Food and Drug Administration (FDA) approved Bausch & Lomb’s 510(k) (K031646) for “Bausch & Lomb Multi-Purpose Solution NRC03”.

May 19, 2004 – The Food and Drug Administration (FDA) approved Bausch & Lomb’s 510(k) (K033854) for “Bausch & Lomb Multi-Purpose Solution NRC07”.

Note: This is ReNu with MoistureLoc.

4th Quarter, 2004 – Bausch & Lomb, with much fanfare, launched ReNu with MoistureLoc.

June 29, 2005 – Bausch & Lomb filed a Summary 510(k) (K051755) for a product they called “Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution” and “Bausch & Lomb Multi-Purpose Solution NRC03”. Under “Predicate Devices” and “Description of Device” Bausch & Lomb describes the solution:

Predicate DevicesAlcon OPTI-FREE Express Multi-Purpose Disinfecting Solution and Ciba Vision AQuify Multi-Purpose Solution have been selected as the predicate devices for Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution.

Description of Device

Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranatee (hydroxyalkylphosphonate), poloxamer 407, polyquatemnium- 10, poloxamine 1107, purified water and preserved with alexidine dihydrochloride (0.00045%). (emphasis added)

NOTE: The only difference in this 510(k) and in the 510(k) for “Bausch & Lomb Multi-Purpose Solution NRC07” is a new indicated use was added for “silicone hydrogel lenses”.

NOTE: This 510(k) did not reference as a “Predicate Device” either of the 2 previously filed and approved devices for “Bausch & Lomb Multi-Purpose Solution NRC03” or “Bausch & Lomb Multi-Purpose Solution NRC07”. Interestingly, NRC07 is ReNu with MoistureLoc.

NOTE: About this time, reports from Asia are coming out regarding an increase in Fusarium keratitis. See: July, 2005. Is it reasonable to think Bausch & Lomb had spontaneous reports prior to the July, 2005 meeting?

July, 2005 – Ophthalmologists at the Hong Kong Hospital Authority, while holding a periodic review, voiced concern about “an unusually high yield of Fusarium from patients’ clinical specimens sent for culture” (per the authority pronouncement on May 20, 2006).

August, 2005 – Hong Kong Health Department put out a public alert about a recent outbreak of 4 cases of keratitis. They warned the public to clean contact lenses carefully. No connection to Bausch & Lomb ReNu products is mentioned.

October 20, 2005 - Hong Kong health officials formally placed Bausch & Lomb on notice of a potential link between the outbreak of keratitis and ReNu with MoistureLoc. Apparently Bausch & Lomb didn’t inform the Food and Drug Administration (FDA) of this notification, the Singapore Ministry of Health (MOH) or Malaysia health department of the Hong Kong action.

November 11, 2005 – After no response by Bausch & Lomb to the October 20, 2005 notice, Hong Kong health officials again formally placed Bausch & Lomb on notice of a potential link between the outbreak of keratitis and ReNu with MoistureLoc. Apparently Bausch & Lomb didn’t inform the Food and Drug Administration (FDA) of this notification, the Singapore Ministry of Health (MOH) or Malaysia health department of the Hong Kong action.

November 17, 2005 – The Food and Drug Administration (FDA) approves the 510(K) filing by Bausch & Lomb for ReNu with MoistureLoc, issuing a “substantially similar” letter to Bausch & Lomb regarding their Summary 510(K) application.
December, 2005 – Malaysia health department started an investigation into the spike of fugal corneal infections recently observed in Malaysia.

Lens solution blamed for eye infection

Wed, 23 Aug 2006 00:00:00 -0700

A U.S. agency and eye doctors reportedly agree the ReNu With Moisture Loc contact lens solution alone was responsible for an eye infection outbreak this year.

But the research led by Dr. Douglas Chang, a fungal disease specialist at the Centers for Disease Control, said it was not clear how the solution made by Bausch & Lomb caused the problem, reports The New York Times. The findings are to be published in The Journal of the American Medical Association.

In an accompanying commentary in JAMA, two academic researchers urged more study to determine the safety of various brands of "multipurpose" lens care solutions, the report said.

On Moisture Loc, Bausch & Lomb had cited as a major factor for the outbreak customer failure to properly clean their lenses and regularly replace the storage solution, the Times reported.

Bausch & Lomb withdrew Moisture Loc from U.S. markets in April and later announced a worldwide recall. The latest study said the number of confirmed new infection cases has slowed to a trickle since the recall, the report said.

It also found no evidence of unusual risks with ReNu MultiPlus, which Bausch is using as a replacement.

CDC Report on ReNu with MoistureLoc May Exacerbate Legal Problems for Bausch & Lomb

Wed, 23 Aug 2006 00:00:00 -0700

CDC researchers believe that the global recall of Bausch & Lomb’s ReNu with MoistureLoc has stopped the outbreak of fusarium keratitis, a serious fungal eye infection. However, the CDC report stated that poor hygiene was not the sole cause of the fungal infections, and said that the contact lens solution appears unable to adequately disinfect contact lenses. While the recall has potentially saved thousands from future infection, the CDC research may have hurt Bausch & Lomb’s ability to defend itself in numerous lawsuits filed against the company. Analysts have estimated Bausch & Lomb faces $500 million to $1 billion in potential liability from the infections, but many plaintiff attorneys believe the liability is much greater.

As of June 30, the researchers had identified 164 confirmed cases of the fungal infection fusarium keratitis. Of those, 94 percent, or 154 patients, wore soft contact lenses. Infected patients came from 33 states and one U.S. territory and about 34 percent of them required a corneal transplant. According to the study, infected contact lens wearers were 20 times more likely to have used Bausch & Lomb’s ReNu with MoistureLoc lens solution than another solution.
While the number of reported CDC cases is alarming, a prominent plaintiff attorney believes the number of infected patients could be in the thousands. Jerrold Parker, a founding partner of Parker & Waichman, LLP, said his firm has already been retained by over 600 plaintiffs and they continue to evaluate hundreds of additional cases. Mr. Parker indicated that his firm is also investigating the disinfectant qualities of other multi-purpose solutions. Some researchers believe that all multi-purpose contact lens solutions fail to effectively sterilize contact lenses.

In the meantime, CDC researchers appear happy that they’ve begun to understand what lead to the fungal outbreak. “We feel pretty confident that the outbreak is over,” said CDC researcher Benjamin Park, who has studied the outbreak since the first reports of the infection in the United States in early March. The report by Park and colleagues at the CDC in Atlanta appeared in the August 23-30 issue of the Journal of the American Medical Association.

CDC: B&L methods not to blame in infections

Tue, 22 Aug 2006 00:00:00 -0700

Bausch & Lomb Inc.’s manufacturing methods were probably not to blame for the outbreak of a rare eye infection among contact lens wearers associated with the use of a popular B&L lens solution, public health investigators have concluded.

The Centers for Disease Control and Prevention have said in an article to be published tomorrow that it was “unlikely” that B&L’s ReNu with MoistureLoc solution came into contact with the fungus causing the infection during the production process.

Instead, the study to be published in the Journal of the American Medical Association, suggests that the outbreak of Fusarium keratitis, a sight-threatening infection, “may” have been caused by a complex and undetermined interaction between MoistureLoc, the Fusarium fungus and, possibly, the lens case or contact lens itself.

B&L said the CDC study “confirms that Bausch & Lomb took the right action in the interests of consumer health and safety by recalling the MoistureLoc product, and that Bausch & Lomb can continue to recommend its ReNu MultiPlus solution with confidence.”

The major conclusion of the study, according to its chief author, is to confirm that contact lens wearers should not use ReNu with MoistureLoc. B&L recalled the product worldwide in mid-May.

Investigators noted that MoistureLoc contains two ingredients not found in other soft contact lens solutions currently on the market, and that those unique properties “may have contributed” to fungal infection in certain instances.

The CDC’s results support both preliminary conclusions made by the Food and Drug Administration in May as well as the company’s own investigation. Executives told the Democrat and Chronicle in May that there was enough evidence to show that a polymer in the formula was an inadvertent culprit.

“This has been a very unique situation, a very unique outbreak,” said Dr. Douglas Chang, an officer with the epidemic intelligence service with the CDC.

The CDC said in its paper it had identified 164 cases of Fusarium by June 30. Those with the infection were statistically more likely than not to be users of MoistureLoc.

Eye cleanser now off the market

Tue, 22 Aug 2006 00:00:00 -0700

A popular contact lens solution is now off the market because of its link to infection, but there's more to the story.

Researchers investigated the infection outbreak and its link to the solution and found that while there was a connection, proper lens hygiene still plays an important role.

Renu with Moistureloc, a contact lens cleaning solution that was taken off the market in May after some people using it got a painful eye infection called Fusarium Keratitis.

Benjamin Park of the U.S. Centers for Disease Control and Prevention says, "This Fusarium Fungus is very common and is in fact everywhere in the environment. It's very commonly found in bathrooms and sinks and other water sources.”

Dr. Benjamin Park and his colleagues at the U.S. Centers for Disease Control and Prevention collaborated with health officials from 33 states, and with the Food and Drug Administration, to investigate the Fusarium infection outbreak.

Their findings appear in JAMA, the Journal of the American Medical Association.

Park also says, "There were 164 confirmed cases of Fusarium Keratitis and we found that users of Bausch and Lomb's Moistureloc solution were over 20 times more likely to get this infection than people who didn't use this solution."

In about 1/3 of the cases, the infection was so severe that patients required a corneal transplant to prevent blindness. Investigators found no contamination in the manufacturing process, or in any of the contact lens products they tested, so what's the link between Moistureloc solution and this infection?

Park says, "That is really the subject of more research, to figure out exactly what it is about the composition of the solution that allows the Fusarium fungus to grow."

Dr. Park says regardless of the solution, practice proper lens cleaning and care. Contact lens expert Michael Ward agrees. Ward of Emory Eye Center says,” Infections are rare and they're usually caused by a breakdown in hygienic practice. Of course the number one thing everyone needs to do is wash their hands prior to ever touching the contact lens."

He says this much is clear to see, following your doctor's instructions for usage, care and cleaning of your lenses will help protect your eyes from infection.

Bausch and Lomb took its Moistureloc formula off the market in May and since then there have been very few reported cases of this infection.

Bausch & Lomb lens debacle studied

Tue, 22 Aug 2006 00:00:00 -0700

U.S. officials said Tuesday they have learned more about a cluster of cases of an eye infection linked to lens solution ReNu with MoistureLoc.

Earlier this year, the product which Bausch & Lomb withdrew from the market -- was blamed for an outbreak of the corneal infection Fusarium keratitis in contact lens wearers.

Fusarium keratitis, a fungal infection of the cornea, can lead to permanent blindness or the need for corneal transplantation.

The Centers for Disease Control and Prevention (CDC) said it has received 164 reports of Fusarium keratitis infections between March and June 30, 2006.

Fifty-five of these patients required corneal transplants.

In response, CDC researcher Douglas Chang led a group of scientists in a search to determine the specific activities, contact lens hygiene practices, or products associated with the outbreak.

Since 94 percent of the infected patients wore soft contact lenses, the team compared data on 45 of them with data on 78 healthy, lens-wearing controls. They discovered that patients were 20 times more likely than the control group to report that they used ReNu with MoistureLoc.

The use of ReNu MultiPlus solution was similar among case patients and controls and was not associated with the infection.

No infection was found at the manufacturer's factory, warehouse, or in unopened solution bottles of implicated lots, so the team has hypothesized that contamination took place in patients' homes and the solution was not able to neutralize the organism.

The researchers said they are conducting tests to confirm their theory, but have advised all soft contact lens wearers to discontinue the use of the product.

The CDC report appears in the August 23/30 issue of the Journal of the American Medical Association.

Eye fungus culprits: solution, hygiene

Tue, 22 Aug 2006 00:00:00 -0700

Federal health investigators narrowed the cause of a mysterious outbreak of a potentially blinding eye fungus that affected scores of people earlier this year to poor hygiene practices and a cleaning solution made by Bausch & Lomb.

The report, in this week's Journal of the American Medical Association, said there were 164 confirmed cases. Users of the ReNu with MoistureLoc solution were 20 times more likely to get the infection than people who did not use that brand.

"We found that overwhelmingly MoistureLoc contact lens solution posed a high risk," said Dr. Benjamin J. Park, an epidemiologist on the investigative team at the Centers for Disease Control and Prevention. "The source of the infection was people's homes."

Park said that the "genetic diversity" of the fungus, Fusarium keratitis, they found after tests of contact lens cases, the factory and unopened bottles indicated that improper care contributed to the outbreak.

"This bug is a fungus that can be found in many different areas, including sinks and drains. The next question is why this one solution," Park said.

Dr. Marcelle Morcos, chief of the ophthalmology at the Nassau University Medical Center, said eye care experts speculate that a special disinfectant in the solution was the culprit.

"When it dries a little on the cornea it could be a good .medium for the fungus to grow," Morcos said. "There could have also been outside contamination."

Fifty-five people, or 34 percent, needed a corneal transplant, the report found.

In an accompanying commentary, other researchers called for additional study of all multipurpose lens-care solutions being sold similar to MoistureLoc to determine their safety.

In a statement on its Web site acknowledging the CDC report, Bausch & Lomb said: "We are working with eye care practitioners to create an ongoing discussion with contact lens wearers about proper care of their lenses and their eyes."

The company pulled MoistureLoc from the market in early April when the CDC announced it was investigating the outbreak.

The eye fungus infection whose symptoms include blurred vision can scar the cornea and blind its victims.

Park said that the CDC's investigation continues.

One-Third of Infected ReNu with MoistureLoc Users Needed Corneal Transplants

Tue, 22 Aug 2006 00:00:00 -0700

A research report issued by the Centers for Disease Control and Prevention revealed that one-third of patients with a serious eye infection associated with Bausch & Lomb’s ReNu with Moistureloc contact-lens solution had such severe infections that they had or will need a corneal transplant. The research report will appear in the Aug. 23/30 edition of the Journal of the American Medical Association.

ReNu with MoistureLoc, was removed from worldwide markets in May after it was linked to several cases in the United States and Asia of fusarium keratitis, a serious fungal infection that can cause blindness.Between June 1, 2005 and June 30, 2006, the CDC said it identified 164 confirmed cases of fusarium keratitis in the U.S. Of those, 94 people reported using ReNu with MoistureLoc and another 21 people reported using that solution along with others to clean their contact lenses. The May CDC report confirmed 130 cases of the eye infection in the United States. Researchers said 55 people either underwent or planned to have a corneal transplant as a result from damage caused by the infection.

“We think that there’s something about the chemical make-up of the solution that allows the fungus to grow and cause infection,” said study senior author Dr. Benjamin J. Park, medical officer with the U.S. Centers for Disease Control and Prevention. “We don’t know the exact mechanism, but it’s important that users of solution don’t use Moistureloc.”

Numerous lawsuits have already been filed against Bausch & Lomb on behalf of people injured by ReNu with Moistureloc. The number of cases is expected to rise dramatically as attorneys are able to clearly link the eye infections with the Moisureloc solution. Parker & Waichman, LLP, a New York personal injury law firm, confirmed that they have been retained by over 600 ReNu users who claim to have been injured by the products. The firm, which has already filed several cases against Bausch & Lomb, plans to file hundreds of additional cases over the next 12 months.

Recalled contact solution from Bausch and Lomb a source of pain for some in Grand Island

Wed, 09 Aug 2006 00:00:00 -0700

It was June 24 when Cindy Branting noticed slight discomfort in her eye during a family trip to Grand Island. Last week, after weeks of indescribable pain, medication and difficulty, she was finally given a clean bill of health.

"I was fortunate we were able to catch it when we did," said Branting, who lives in Shelby. "If it had gone untreated much longer, it could have done serious damage. Right now, I don't think there's any major vision loss."

Branting contracted a fungus in her eye known as Fusarium Keratitis, most likely from a recalled contact solution called ReNu with MoistureLoc distributed by Bausch and Lomb. While the company recalled the product in March because of problems with Fusarium Keratitis, Branting, who works at Annie Jeffrey Memorial Hospital in Osceola, didn't hear of the recall.

Now that her ordeal is almost over, after she painfully applied medication every hour and underwent procedures where doctors scraped her cornea, she's keen to let others who might still be using the product know of the dangers.

She's not alone. Dr. Michelle Gleason of Gleason-Janky Eye Physicians in Grand Island said she has seen patients still using the ReNu with MoistureLoc months after the recall went out.

"I had a patient (Branting) who had an infection and did OK with it, but I had a patient come in recently who was still using that solution," she said. "Sometimes people buy a lot at a time and they could be at risk. We wanted the public to be very aware of this situation."

Gleason said if you've used ReNu with MoistureLoc recently and not suffered any symptoms such as pain or intense itching, you have nothing to worry about but should throw away the rest of your supply.

If you've used it in the past and not seen any symptoms, you're similarly in the clear, though Gleason said you're at risk if you continue to use the solution.

Fusarium Keratitis begins with minor irritation but progresses quickly. In Branting's case, she first noticed a problem on a Saturday and experienced intense pain the next day while traveling to Omaha to take her daughter to Children's Hospital, where she had a surgery scheduled.

"It was so bad I walked across the street (from Children's Hospital) and went to the ER at Methodist," she said. "By that Tuesday, I couldn't even function. I couldn't tell how bad it hurt. It felt like there were razor blades in my eye."

The ER initially diagnosed her problem as "gouges in my cornea," but when the problem didn't resolve itself, Branting sought out a specialist and found Gleason. To treat the infection, Gleason prescribed drops that caused blistering on Branting's eyelids and had to be administered once an hour, every hour, even during the night.

While the disease is serious, it appears as if Branting escaped any major lasting damage to her eyes. But it's too early to be sure. More importantly, she knows of others who didn't hear about the recall and were using ReNu with MoistureLoc, unaware of the possible dangers.

Gleason says it's important for people to understand eye disease and work to prevent it.

"Any time a patient has a red eye, they need to come in and be seen," she said. "The earlier we catch this stuff, the better."

Experts: Lens solution still a risk

Mon, 31 Jul 2006 00:00:00 -0700

People still using the ReNu with MoistureLoc contact-lens solution need to stop, Kenneth Goins, a University of Iowa clinical associate professor of ophthalmology, said Thursday.

And they need to stop now.

"I've just seen too many patients and too many problems with it," he said.

The product was recalled May 15 voluntarily by its manufacturer, Bausch & Lomb, but the UI Hospitals and Clinics are still experiencing MoistureLoc effects. Goins said he has approximately a dozen cases presumed to be related to use of the solution.

The company removed it from the market because of its possible link to Fusarium keratitis, a dangerous, sight-threatening fungus infection.

"(The infection) is very difficult to treat," said Goins, who specializes in corneal and external diseases. "In our series here, about 25 percent of those patients have needed cornea transplants."

The U.S. Centers for Disease Control and Prevention reported an increased risk for the infection among MoistureLoc users, although the cause of the association is not clear.

Christine Sindt, a UI clinical assistant professor of ophthalmology, noticed a problem with the solution almost two years ago when she conducted her own informal study. When MoistureLoc was released in November 2004, she was eager to create a personal assessment of it.

"I always like to test the new products test-drive them, so I can develop an opinion," Sindt said.

Contact lenses sat soaked in three different solutions overnight. The following day, Sindt examined five volunteers from her office for corneal staining, the presence of dead cells on the eye. Volunteers then wore a pair of the contacts for one to two hours and were examined again.

Sindt, also the director of UIHC's contact-lens service, said the lenses soaked in MoistureLoc produced an "unusual" amount of staining, named because of a dye's adherence to dead cells.

She immediately expressed her concern with Bausch & Lomb's public relations director, who told her he was certain the solution had undergone appropriate studies and had passed. When the director, Fred Edmunds, said the company had not conducted tests that could measure corneal damage over time, she urged him to do so.

"The eye heals itself in about eight hours," Sindt said. "So the most staining would be noticeable in one to two."

Then, she waited.

"I felt like at that time I had done my part to voice my concern, and I handled the information appropriately within my own practice when I recommended solutions to my own patients," Sindt said.

Meanwhile, contact wearers worldwide using the MoistureLoc solution began reporting cases of fungal infections.

Goins said Sindt developed the theory that a new preservative in the formula could get "trapped" in the lens, causing both the corneal staining and infection vulnerability.

"If her theory is true," he said, "the increased preservative in the lens would lead to a breakdown in corneal epithelial surface cells, thereby allowing pathogens direct access to the cornea, so they may be directly linked."

Bausch & Lomb, in a report issued May 19, stated it will continue searching for a cause of Fusarium keratitis. Representatives from the corporation could not be reached for comment Thursday afternoon.

With MoistureLoc pulled from store shelves, the threat of its damage remains behind medicine cabinet doors. And until the culprit causing these infections is identified and its inclusion in future solution products permanently banned, Sindt wants only to know one thing: "How long can you beat a dead horse?"

de la O, Marko, Magolnick & Leyton, P.A. and Parker & Waichman, LLP to Represent Citizens of Asia Against Bausch & Lomb, Maker of Renu With MoistureLoc Contact Lens Solution - BOL

Fri, 21 Jul 2006 00:00:00 -0700

The American law firms of de la O, Marko, Magolnick & Leyton, P.A. and Parker & Waichman, LLP announce they have been retained by citizens of Asia who have suffered severe damage to their eyes as a result of using Bausch & Lomb's (NYSE:BOL) ReNu with MoistureLoc(r) brand contact lens solution. de la O, Marko, Magolnick & Leyton and Parker & Waichman have been retained by many ReNu victims in the United States and abroad, all of whom have suffered severe injuries due to Bausch & Lomb's contact lens solution, including injuries requiring corneal transplant surgery and resulting in permanent vision loss.

One of the Asian clients, Teck-Meng Yong, was one of the first ReNu victims in Singapore to undergo a corneal transplant as a result of severe damage caused by the Fusarium fungus he contracted while using Bausch & Lomb's ReNu with MoistureLoc(r) brand contact lens solution. Another client from Asia is 19 year old Jermaine Tan, also from Singapore. In January of this year, Mr. Tan also underwent a corneal transplant as a result of severe damage caused by the Fusarium fungus contracted while using ReNu with MoistureLoc(r). Joel Magolnick, a partner at de la O, Marko, Magolnick & Leyton, stated, "According to Jermaine's doctors, the Fusarium fungus had almost eaten all the way through the cornea. One more day and it could have been too late. If Jermaine had not been treated in time, doctors would have had to remove his entire eye." Jermaine Tan has only recovered about 60 percent of the sight in his left eye, and his vision remains impaired.

Fungal keratitis is a severe infection of the cornea. Fusarium keratitis, one type of fungal keratitis, is often accompanied by symptoms of eye pain/discomfort, excessive watering or discharge from the infected eye, decrease in vision and increased sensitivity to light. Risk factors for infection usually include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiencies and, very rarely, contact lens use. An estimated 30 million persons in the United States wear soft contact lenses; the annual incidence of microbial keratitis is estimated to be 4-21 per 10,000 soft contact lens users. Fungal keratitis is a condition more prevalent in warm climates. First-line treatment includes topical and oral antifungal medications; patients who do not respond to medical treatment usually require surgical intervention, including corneal transplantation. These infections are not transmitted from person to person. If not timely treated, Fusarium keratitis may lead to complete destruction of the cornea and loss of the eye itself.

In February 2006, Bausch & Lomb ceased sales of all ReNu(r) solutions in Singapore and Hong Kong after many users of ReNu with MoistureLoc(r) were diagnosed with Fusarium Keratitis. As of May 2006, researchers in Singapore had found 80 cases of Fusarium keratitis among contact lens wearers, nearly all of whom used ReNu with MoistureLoc(r).

On May 15, 2006, Bausch & Lomb announced that it was permanently removing ReNu with MoistureLoc(r) from the market worldwide. That same day, the FDA issued a press release stating: "Based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium, Bausch & Lomb has decided to permanently remove the ReNu with MoistureLoc product worldwide." The recall followed Bausch & Lomb's conclusion that the product's formula may increase the risk of fungal eye infections in certain situations. Bausch & Lomb, Inc. and the FDA both acknowledged there is a problem in the chemical properties of ReNu with MoistureLoc after testing confirmed that the solution allows a polymer film to form around the Fusarium fungus, preventing the disinfectant in the product from killing the fungus.

More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca

CONTACT: de la O, Marko, Magolnick & Leyton, P.A.
         Joel S. Magolnick, Esq.
         (305) 285-2000
         Toll free: (888) 893-5723
         magolnick@dmmllaw.com
         www.dmmllaw.com

         Parker & Waichman, LLP
         Jason Mark, Esq.
         (212) 267-6700
         Toll free: 800-LAW-INFO
         or (800) 529-4636
         info@yourlawyer.com
         www.yourlawyer.com
         www.renulawsuit.com

Consumers plan lawsuit against contact lens maker

Tue, 11 Jul 2006 00:00:00 -0700

Nearly 80 Chinese citizens who claim they suffered eye infections caused by a contact lens solution made by Bausch & Lomb plan to sue the company in the United States.

They believe they contracted fungal keratitis, which can lead to blindness, after using ReNu MoistureLoc Multi Purpose Solution.

The lawyer representing the group, told China Daily yesterday that less than 10 had so far provided sufficient evidence to back up the claims.

"I have sent full medical documents of three infections to my partner in the United States," he said yesterday.

Sources with Bausch & Lomb China said they would not comment over the cases until they had been processed, China Business News previously reported.

The Chinese lawyer, said he believes the company made a mistake by not informing Chinese consumers of the quality problem after it recalled products in Singapore in February.

Where exactly to sue the US company has not yet been decided, the lawyer said.

"To sue Bausch & Lomb in New York State, where its headquarters are located, is a possibility. But we are also considering suing the company in a state where higher compensation is likely," the lawyer said. A date has yet to be fixed to file the lawsuit, he added.

In the United States, the number of confirmed cases of the rare fungal eye infection that can cause blindness has climbed to 122. Most of them are contact-lens wearers who reported using Bausch & Lomb's ReNu MoistureLoc Multi Purpose Solution, US authorities said in May.

It is believed that some American consumers have brought lawsuits against Bausch & Lomb for compensation. No judgements have been reported yet.

Reports in April said that Bausch and Lomb found no eye infections in China linked to the cleaning solution. Company chief executive Ronald Zarrella said that in China the solution was made locally and not imported from the United States.

Healthcare professionals in ReNu study honoured

Mon, 10 Jul 2006 00:00:00 -0700

A team of Singapore healthcare professionals were the first to alert the world on a link between a ReNu contact lens solution and a global spike in fungal corneal infections.

These professionals have been honoured for not only daring to take on a pharmaceutical giant but also for saving the sight of many contact lens users.

The team of eye doctors and researchers were the first in the world to discover the link between Bausch and Lomb's ReNu MoistureLoc contact lens solution and the rising cases of fungal corneal infections.

The discovery came after some nifty investigation work, and throughout the investigation process, high stakes were involved.

Health Minister Khaw Boon Wan said: "Certainly when you decide to do something like this, you're taking on a very big multi-national corporation and as I said, they're armed with teams of (scientists and) lawyers. And if the advisory was pre-mature or without basis, or could not be proven, I'm quite sure there'll be a legal suit on our table.

"But more than legal suits, it's also our own reputation. In this instance, the reputation of SNEC and of course Ministry of Health and Singapore. So I'm quite glad. More importantly it ended up well."

Associate Professor Donald Tan, Deputy Director of the Singapore National Eye Centre (SNEC), said: "I think it was speed which saved a lot of patients, not only in Singapore but also elsewhere. So we're very happy that we were able to do that.

"In the US, one third of the patients actually required corneal transplants. So it's very severe, and a lot of it is because of delayed diagnosis. For us, we have five transplants out of 68 cases. So the severity was much less. So our patients did not suffer as much. They had better visual outcomes because we got into it earlier."

To recognise their vigilance, professionalism, dedication and courage, the team of eye doctors and researchers were given the Health Minister Awards on Monday.

Another team of healthcare professionals also received the Minister of Health award.

Stores Wipe Eye Solution Off Shelves, Finally!

Thu, 06 Jul 2006 00:00:00 -0700

The manufacturers of an ophthalmic solution suspected of causing eye infections is actively pulling out the product from the Saudi market, according to a statement issued yesterday by the Saudi Ophthalmology Society.

On June 26, Arab News reported on the selling of ReNu with MoistureLoc in pharmacies here despite announcements over a month ago by Bausch & Lomb that it was recalling the product from markets worldwide. The manufacturers announced their decision in May after an outbreak of a fungal eye infection in the US was linked to the use of the products.

The Saudi Ministry of Health also issued a precautionary note and later sent circulars to pharmacies to remove all ReNu products from their shelves, but even after removing them ReNu with MoistureLoc was still available for sale.

Pharmacies visited by Arab News last week said they were not aware of the circular or of the harm the product might cause to the eye.

The Saudi Ophthalmology Society issued a statement that its chairman, Prince Abdul Aziz ibn Ahmed, had directed the society to follow up on the international developments.

The society’s board member and joint president of the International Association for Combating Blindness in the Middle East, Dr. Abdul Aziz Al-Rajhi, said that the society sent an official letter to the company inquiring on the reports and local sales representative’s actions in the Kingdom in response to the recall.

Al-Rajhi said that the company’s initial response was that the product being sold in the Kingdom came from a European plant, and not the US plant that was linked to the outbreak of the infection. Later, the company decided to recall the entire line, regardless of where the product was manufactured.

Al-Rajhi said that the company assured the society that it is currently pulling out voluntarily ReNu with MoistureLoc from the Saudi market and sent letters and press releases to ophthalmologists not to use the product, and supplying them with ReNu Multiplus instead.

In a statement issued by the US Food and Drug Administration (FDA) on May 15, scientific and epidemiological data suggested that ReNu with MoistureLoc may increase susceptibility to Fusarium and that Bausch & Lomb has decided to permanently remove the product worldwide.

Other ReNu brand products were not found to have any problems at that time, although there have been some allegations that ReNu MultiPlus users have contracted the fungal eye infection.

Meanwhile, the FDA and the Centers for Disease Control and Prevention are investigating the multistate outbreak and have sent field officers to inspect the Bausch & Lomb plant and facilities in Greenville, South Carolina, one of the plants where the product is manufactured.

“ReNu with MoistureLoc contact lens solution, manufactured in the Greenville, SC plant, was voluntarily withdrawn from the market in the United States on April 13, 2006. To date, a majority of the confirmed Fusarium cases have been associated with the ReNu with MoistureLoc,” said the FDA statement.

Contact lens fungus link to blindness

Wed, 28 Jun 2006 00:00:00 -0700

Contact lens wearers have been warned about a new fungus that can lead to blindness, after an investigation found that 200 people in the United States and the Far East have contracted the condition.

The infection called fusarium keratitis has prompted the withdrawal of one type of lens cleaning solution used by many of those affected.

But people with poor contact lens hygiene also appear to be at increased risk of catching the infection, which was described as "the most severe complication related to contact lens wear" by researchers.

Several of those infected in the outbreak are expected to need corneal transplants to fully restore their sight.

Experts said it was rare in Britain, but advised anyone travelling to hot and humid climates, where the fungus is more common, to switch to daily disposable contact lenses to avoid the risk associated with wearing longer-lasting lenses.

In a paper published in today's edition of the Journal of the American Medical Association, scientists at the Singapore Eye Research Institute (SERI) said the three outbreaks "suggest that this phenomenon may be part of a global problem, with serious implications for millions of lens wearers worldwide".

They said the infection rate in Singapore with 2.35 cases out of every 10,000 people wearing contact lenses was an "astounding figure".

They continued: "We believe that Singapore is facing a new and unprecedented outbreak of fusarium keratitis and that this is the first time that such an outbreak has been reported among contact lens wearers anywhere in the world.

"By highlighting this serious outbreak of fusarium keratitis among contact lens wearers in Singapore, we hope to alert physicians and other eye-care clinicians worldwide to maintain a high index of suspicion for fungal infections."

The researchers said 7.4 per cent of those infected in Singapore needed "urgent surgical intervention to treat acute corneal perforation" or to stop this from happening. "It is likely that additional cases may require subsequent corneal transplantation for residual scarring."

Nearly all patients wore soft, disposable contact lenses and just under two-thirds reported using a cleaning fluid called ReNu with MoistureLoc.

This was withdrawn from the market worldwide this year, with the manufacturer, Bausch & Lomb, saying some part of the formula "may be increasing the relative risk of fusarium infection in unusual circumstances".

However, Professor Roger Buckley, a former president of the British Contact Lens Association, has said he believes the apparent link with the MoistureLoc fluid was simply because it was so commonly used in Singapore, adding "it is likely that the cause will be found elsewhere".

To date, fungal keratitis has been rare in the UK. ISD Scotland, which collates statistics from the NHS and Scottish Executive, said it did not have any relating to the condition. Donald Cameron, a leading Edinburgh optometrist, said he had never seen a single case in 30 years, while Dr Stuart Roxburgh, a leading eye specialist at Ninewells Hospital in Dundee, said he saw about one case in every two years.

Pharmacies Ignore Pullout Order, Sell Harmful Ophthalmic Solution

Mon, 26 Jun 2006 00:00:00 -0700

Despite the announcement a month ago by the manufacturers of a highly harmful ophthalmic solution that they were recalling the product, the item is still available in pharmacies across Jeddah.

Bausch & Lomb, the manufacturers of the contact lens clearing solution ReNu with MoistureLoc, announced their decision to call back the product from markets worldwide due to a high rate of eye infection associated with it. The Saudi Ministry of Health also issued a precautionary note around the same time.

Pharmacies visited by Arab News said they were not aware of the circular or of the harm the product might cause to the eye until last week. Although many pharmacies have removed the product from their shelves, some continue to sell it.

According to a statement issued by the US Food and Drug Administration (FDA) on May 15, the multinational eye care company Bausch & Lomb, which has its headquarters in Rochester, New York, decided to permanently withdraw ReNu with MoistureLoc due to data suggesting that the liquid may increase susceptibility to Fusarium Keratitis, a fungus that causes an eye infection affecting the cornea and which can lead to total blindness.

The Centers for Disease Control and Prevention (CDCP) is investigating the multi-state outbreak of Fusarium Keratitis that may be associated with contact lens use.

However, the risk of getting the fungus from contact lenses remains extremely low. Contact lens wearers who experience unusual redness, pain, tearing, light sensitivity, blurry vision, discharge or swelling should consult their doctor immediately. The CDCP is continuing its investigation to identify specific factors that may have placed people at risk for developing the infection, including hygiene practices, overnight usage and specific solutions used.

The Saudi Ministry of Health issued warnings in the local papers a month ago about possible infections associated with the use of ReNu with MositureLoc. Last week pharmacies began receiving a circular from the ministry ordering them to remove all ReNu brand products. They were also informed of the pullout by the distribution agent.

“I only found out about the circular a few days ago from my neighbor who is an optician,” said pharmacist Mohammed Fathi.

The optician, Osama Hussein, said many pharmacists he encountered have not read the reports in the papers nor have they received the circular. “There hasn’t been any follow-up from the ministry to check on whether the product has been removed from the shelves or whether it is still being sold,” he said.

ReNu products, especially ReNu Multiplus, are the most common brands bought by contact lens users, according to pharmacists.

Manal Ahmed, 36, has been using ReNu for the past seven years. She bought ReNu with MoistureLoc last week from a local supermarket and did not know that it was harmful and was supposed to be pulled out.

“This (Fusarium Keratitis) is a very rare type of fungus and we have not received any cases here until now,” said Dr. Ihab El-Hawary, ophthalmology consultant at El-Maghrabi Eye Center on Madinah Road. “Although it might affect contact lens wearers, especially those who use distilled water to clean their lens, it mainly affects people who work in agriculture or have low immunity due to diseases such as cancer, uncontrolled diabetes or have some kind of organ transplant,” he explained.

Even if there were some cases in the Kingdom, they might not have been reported or diagnosed correctly, said Dr. El-Hawary.

More Fungal Eye Infections

Wed, 14 Jun 2006 00:00:00 -0700

Fungal infections of the eye are on the rise, according to a report published this week.

A recent spate of fungal infections was widely reported in the media. All infections were linked to contact lens use, and some were linked to Bausch & Lomb's ReNu MoistureLoc contact cleanser solution. The company permanently pulled the product from the shelves.

Now, a report from researchers at the University of Miami raises questions about what is really behind the growing number of infections.

The University of Miami Miller School of Medicine reports 34 cases of fungal keratitis associated with soft contact lens use between January 2004 and April 2006. Compare that to the previous numbers from the same institution: only three cases of fungal keratitis between 1969 and 1977, two between 1977 and 1982 and five between 1982 and 1992.

The most recent 34 cases were all associated with a particular kind of fungus known as Fusarium. Only 13 of the patients could remember what kind of contact lens solution they used. Of the 13, 12 reported they used some sort of ReNu brand solution.

The researchers also report it is important to make the diagnosis of a fungal eye infection as quickly as possible. The sooner anti-fungal treatment was administered, the better the outcomes for the patients were.

Local Eye Infection Case Confirmed

Tue, 13 Jun 2006 00:00:00 -0700

One of 14 incidents in Tennessee of a fungal eye infection linked to a popular contact lens solution hails from Hamilton County. "We only had one case reported to us that was lab tested and diagnosed," says D. Marie Stoudemire, an Epidemiology Nurse at the Hamilton County Health Department.

In April, Bausch and Lomb pulled the Renu with Moisture Loc brand from store shelves after the CDC found a possible link between the solution and fusarium keratitis... a plant-borne infection that can cause blindness. Symptoms include redness of the eye, tearing, blurry vision, swelling, pain, and discharge.

Although the health department reports only one local case, John McMahan, who handles product liability suits, says he's received 100's of calls from people suffering from symptoms of fusarium keratitis.

McMahan says "many of these people had no clue whatsoever that Renu had been recalled."

McMahan placed ads on News 12 and stations in Nashville and Georgia warning people about the dangers of this infection, if left untreated. He's preparing a claim against Bausch and Lomb on behalf of those who used Renu with Moisture Loc and suffered an injury, like cornea damage.

"We're claiming that the product itself is defective and is unreasonably dangerous to the consuming public. And we have to prove there's an injury as well. Simply taking or using Renu is not enough," says McMahan.

Both McMahan and the Health Department continue to look for cases of this fungus.

Meanwhile, Bausch and Lomb mailed out letters this month informing customers the Moisture Loc formula will not be reintroduced.

FDA inspections of Bausch & Lomb production plants found deviations in good manufacturing processes. Bausch and Lomb admits exhaustive testing has not eliminated the link between their product and this rare eye infection, although an exact cause remains unknown.

Stats on Fusarium Keratitis:

Of the 14 cases in Tennessee, 10 involved the use of Renu with Moisture-Loc.
6 cases of the infection in Tennessee resulted in serious injury requiring corneal transplants.
Across the country, the CDC reports 122 confirmed cases.

B&L finds cause of recent fungal corneal infection: report

Sat, 10 Jun 2006 00:00:00 -0700

Bausch & Lomb, a famous American eye health company, has found the cause of the recent fungal corneal infection occurring in some 300 contact lens users worldwide, Channel NewsAsia reported Friday night.

The reason lies in the formula of the ReNu MoistureLoc multi- purpose contact lens solution itself which contains three polymers instead of one as found in most of other contact lens solutions.

Having been used to make the eyes of contact lens users more comfortable, the polymers actually trap the fungus and prevent it from being killed by the strong and effective disinfectant in the formula, the report quoted Donald Tan, a local ophthalmologist, as saying.

The company also found that the fungus grows on the tip and the cap of an open solution bottle and that each time a user adds the solution into his contact lens case, the fungus goes into the case as well, according to Tan, who is also the director of the Singapore Eye Research Institute.

The result was unveiled at the 21st Congress of the Asia- Pacific Academy of Ophthalmology, which is being held in Singapore, according to the report.

Bausch & Lomb recalled the MoistureLoc contact lens solution throughout the world on May 15 this year after a sharply increasing number of fungal corneal infection cases had been reported in Hong Kong, Singapore, Malaysia and the United States while a majority of the patients said that they had used this product.

Lens solution the culprit in worldwide contact lens scare

Fri, 09 Jun 2006 00:00:00 -0700

Contact lens maker Bausch and Lomb has discovered that the cause behind the recent spate of fungal eye infections worldwide is the ReNu lens cleaning solution itself.

The findings were released at the first day of the Asia-Pacific Academy of Ophthalmology Congress.

Most contact lens cleaning solutions contain just one polymer, but ReNu MoistureLoc multipurpose contact lens solution has three.

Its manufacturer, Bausch and Lomb, thought this would keep the eyes of contact lens users moist and comfortable, but the formula ended up trapping fungus instead of killing it.

Said Associate Professor Donald Tan, senior consultant ophthalmologist and director of the Singapore Eye Research Institute, "The disinfectant in MoistureLoc is actually very effective. The problem is when you add other things in, like the polymers, to improve comfort. The polymers are actually trapping the fungus so that the disinfectant, which is very strong, cannot get at the fungus. So it is a formulation problem."

And the fungus grows by the day with each repeated use.

Professor Tan said, "Bausch and Lomb has found that in open bottles you can get the fungus growing on the tip and on the cap of the open bottle because of the trapping of the fungus there. And what appears to be happening is that every time you add the solution onto your contact lens case, you actually add in fungus."

But doctors say users themselves must also practice good contact lens cleaning and care regimens.

Some 300 cases of fungal corneal infection have been reported across the US, Malaysia and Singapore.

In Singapore, 90 percent of the 80 patients had used the solutions from the ReNu range; three quarters of them were using ReNu MoistureLoc solution.

The Singapore Eye Research Institute has set up a special task force to study the hygiene habits of some 100 contact lens users, to look into preventing such fungal infections from recurring.

The study would include both healthy contact lens users and those who had the fungal corneal infection.

The institute is also working with microbiologists on a case control study.

ReNu with MoistureLoc still on sale on UK high street

Thu, 08 Jun 2006 00:00:00 -0700

ReNu with MoistureLoc could still be purchased on the UK high street yesterday, more than three weeks after manufacturer Bausch & Lomb announced a worldwide product recall.

Optician visited eight retail outlets in Sutton, Surrey, to assess the effectiveness of the product recall. These included Asda, two independent chemists, three optical practices, Superdrug and Boots the Chemists.

All but the Boots outlet had removed MoistureLoc from their shelves. On Wednesday morning, Optician successfully purchased a 2 x 360ml economy pack from a healthcare assistant at the pharmacy counter.

A spokesman for Boots said its data showed it had been on the whole very successful in withdrawing the stock from sale and in helping customers find alternatives. ‘There have been extremely few cases of stock still being available and in this highlighted case we have been in touch with the store to find out what happened and to ensure they are aware of the issue.

Anecdotal evidence of people still using the multipurpose ‘no rub’ solution raised fears that the message regarding the potential dangers of using the product had not reached all patients.

Roger Oldham, a website director from south-east London, told Optician he was still using the ReNu with MoistureLoc solution earlier this week, having purchased his last batch of solutions in early May.

He was concerned that his optician had not contacted him to tell him of the product recall and warn him of the dangers. Few practices, however, monitor the solutions sold to or used by their patients.

Bausch & Lomb told Optician that on May 18 it had placed a withdrawal advert in the following newspapers: The Independent, the Scotsman, the Irish Times, Metro and the Daily Express. Editorial featured in the Daily Mail, Daily Telegraph, The Times, Metro, Financial Times, Irish Times, Irish Independent, Wall Street Journal and BBC Online.

Last week (News, June 2) the Medicines and Healthcare products Regulatory Agency (MHRA) issued a Medical Device Alert to NHS trusts and PCTs in England, urging action by ophthalmologists, pharmacists, opticians, optometrists or GPs. It recommended that patients should be asked which contact lens solution they use at their next appointment but did not suggest that potential users of the solution should be contacted.

A spokesman for Bausch & Lomb said: ‘Bausch & Lomb contacted all of our customers from the moment we made the decision to withdraw MoistureLoc from worldwide markets. We asked our customers to immediately remove any MoistureLoc product from their shelves and replace it with an alternative solution.

‘We are maintaining an increased level of communication with our customers to ensure that any remaining MoistureLoc product is removed from stores while we increase supplies of Multi-Purpose solution to our customers.’

Man Diagnosed with Fusarium Keratitis After Using ReNu with MoistureLoc Files Lawsuit Against Bausch & Lomb

Mon, 29 May 2006 00:00:00 -0700

Parker & Waichman, LLP Announces It Has Filed Suit on Behalf of Man Diagnosed With Fusarium Keratitis in Left Eye After Using ReNu With MoistureLoc Contact Lens Solution

Victim Underwent Cornea Transplant, Lensectomy, Capsulectomy, Iris Removal and Multiple Flush-Out Surgeries on Left Eye, Awaits FDA Approval for Iris Transplantp> Parker & Waichman, LLP announces that it has filed a suit against Bausch & Lomb, Inc. on behalf of a 53-year-old man who was diagnosed with Fusarium keratitis in his left eye after using ReNu with MoistureLoc. As a result of the infection, the injured man underwent a corneal transplant after several invasive surgical procedures to remove the infection failed. He is currently awaiting FDA approval for an iris transplant. The suit was filed yesterday in the Supreme Court of the State of New York in Onondaga County.

On April 10, 2006 the FDA and the CDC issued public health warnings concerning serious fungal infections associated with contact lens solution use. The CDC stated that it had interviewed 30 patients suspected of having fungal keratitis. Of these 30 patients, 28 wore soft contact lenses and 26 used a Bausch & Lomb ReNu contact lens solution in the month prior to the fungal infection diagnosis. On April 13, 2006 Bausch & Lomb, Inc. recommended that consumers switch to another lens care solution and asked all retailers to remove U.S.-manufactured ReNu with MoistureLoc from their shelves. On May 2, 2006 the CDC announced that the number of confirmed fungal infections rose to 88 cases. Just three days later, on May 5, 2006, the CDC revised the number of confirmed cases to 102.

On May 12, 2006 the CDC made another upward revision in the number of confirmed fungal eye infections to 122 cases. On May 15, 2006 the FDA issued a press release stating: “Based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium, Bausch & Lomb has decided to permanently remove the ReNu with MoistureLoc product worldwide.’’ The recall followed Bausch & Lomb’s conclusion that the product’s formula may increase the risk of fungal eye infections in certain situations. Bausch & Lomb, Inc. and the FDA both acknowledged there is a problem in the chemical properties of ReNu with MoistureLoc after testing confirmed that the solution allows a polymer film to form around the Fusarium fungus, preventing the disinfectant in the product from killing the fungus.

The injured party, who resides in upstate New York, was diagnosed with a fungal infection in his left eye in October 2005, and was referred to a cornea specialist at Columbia Presbyterian in New York City. The specialist performed a corneal confocal microscope exam and several biopsies, which confirmed the diagnosis of Fusarium keratitis. The specialist notified the plaintiff that a cornea transplant would be necessary. Because the transplant procedure could not be performed until the infection was under control, the victim was prescribed voriconazole, a potent anti-fungal medication, which had to be administered approximately every 2 hours, 24 hours each day, over the course of several months. After the infection appeared to be under control, the cornea transplant procedure was performed. During the cornea transplant surgery, additional signs of the fungal infection were discovered. This later led to approximately 5 flush-out surgeries, which involved accessing the back of the left eye through an incision in order to remove additional evidence of the Fusarium fungal infection. The infection returned following the flush-out surgeries, requiring the victim to undergo a lengthy and invasive surgery with the following procedures performed on his left eye: lensectomy, capsulectomy, removal of the iris, removal of vitreous fluid, and removal of the fungal infection. The victim is left with only 15% vision in his left eye and is currently awaiting FDA approval for an iris transplant.

Fungal keratitis is a severe infection of the cornea. Risk factors for infection usually include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiencies, and, rarely, contact lens use. An estimated 30 million persons in the United States wear soft contact lenses; the annual incidence of microbial keratitis is estimated to be 4 — 21 per 10,000 soft contact lens users. Fungal keratitis is a condition more prevalent in warm climates. First-line treatment includes topical and oral antifungal medications. Patients who do not respond to medical treatment usually require surgical intervention, including corneal transplantation. These infections are not transmitted from person to person.

Recalled lens solution back in the eye of the storm

Sun, 28 May 2006 00:00:00 -0700

Three cases of possible fungal eye infection among users of a contact lens solution, linked to a rare disease that causes blindness, have been reported in Dubai, Gulf News has learned.

Renu with MoistureLoc contact lens solution, manufactured by Bausch and Lomb, was permanently recalled recently after US health authorities concluded that it was "the root cause" for an outbreak of Fusarium keratitis among its users.

The FDA and the company found that the solution allowed a polymer to form around the Fusarium fungus, protecting it from the solution's disinfectant.

The three patients Ahmad Al Abbadi, from Egypt, Khalid Al Khatib, from Turkey, and a British national reported using the solution regularly. The first two are currently being treated at the Ophthalmic Ward at Dubai Hospital, while the other has gone to the UK for treatment.

Both Al Abbadi and Al Khatib are angry that Bausch and Lomb and its UAE representatives did not warn their customers about the dangers associated with the solution, although Hong Kong, Singapore and Malaysia first reported an outbreak in February.

Both, who were infected in April, believe the solution was responsible, although lab tests could not determine whether it was a bacterial or a fungal infection. Their treatment includes anti-fungal and anti-bacterial eye drops.

Al Abbadi is convinced that he has a fungal eye infection because he was always careful with personal hygiene.

"It is a fungal infection, most likely from Renu. Because where else am I going to get the fungus?" he asked.

The banking executive said the ulcer in his cornea was still not better, despite the intensive treatment he received in Egypt and in the UAE. He can barely open his left eye. On top of worrying the infection will get worse and blind him, requiring a corneal transplant, he is also worried that he will lose his job.

"I have finished my annual leave, my sick leave (quota). Now I'm entering into half-pay, and (in two weeks) I will be unpaid," he said.

Al Khatib, who was admitted to the hospital in April, told Gulf News that his eye was getting better, although still red and watery with a visible white spot on the cornea.

That did not lessen his anger, however. "It is really frustrating when something that you buy, that you pay for, makes you sick," he said.

Renu with MoistureLoc contact lens solution was available on shelves in the UAE till May 16, although a few pharmacies removed the product after Gulf News highlighted the issue a month before.

An ophthalmologist at the hospital, who declined to be identified, said he did not discount the possibility that the solution was responsible for the infections.

He said the hospital had seen an increase of patients with eye infections due to contact lens use in the last few months.

However, he declined to say how many of them used Renu with MoistureLoc contact lens solution.

Gulf News contacted Ahmad Jaber, managing director of Al Jaber Trading Agencies, UAE agent for Bausch and Lomb, who said he did not believe the solution was responsible as lab tests did not confirm the infection as Fusarium keratitis.

Cases Of Fungal Corneal Infections In Hong Kong

Fri, 26 May 2006 00:00:00 -0700

The Centre for Health Protection (CHP) of the Department of Health (DH) has received one more report of fungal corneal infection (keratitis) this month, bringing the total number of contact lens users affected to 33 since the infection was firstly reported in May 2005.

A CHP spokesman said the newly identified case was a 40-year-old man who attended a public hospital in April this year.

“Of the 33 patients, 32 were interviewed and 29 of them claimed that they used only B&L ReNu multipurpose contact lens solution,” he said.

Preliminary results of case-control study conducted by the CHP in connection with fungal keratitis found a significant association between development of fungual keratitis and the use of ReNu solution among disposable contact lens users in Hong Kong. The association is present even after adjusting for hygiene and other factors.

“The finding is consistent with that from a case-control study conducted in Singapore,” the spokesman said.

Noting that the manufacturer announced a worldwide recall of the ReNu with MoistureLoc Multi-purpose contact lens solution yesterday, the spokesman said DH supported the recall and called on contact lens users to stop using the product including partially used and opened bottles.

The CHP will also continue to monitor the local situation closely.

He reminded contact lens users to observe the following measures to prevent contact lens associated infection:

Always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories.
Attend regular check up by your optometrists/ophthalmologist and follow their instruction of cleaning and disinfection procedures for contact lenses and the accessories.
Follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists. Do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists.
Practise proper contact lens cleaning and care regimes. Both sides of the lenses must be rubbed with the fingers for 20 seconds and rinsed thoroughly before soaking overnight in multi-purpose solution. Rinse the lenses with saline before wearing the contact lenses next time.
The multi-purpose solution in the lens storage case must be changed everyday even if the lenses are not used daily.
Close all bottles of contact lens solution properly after use.
Discard contact lens solutions after one month of opening.
Storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination.
All contact lenses, solutions and accessories should be stored in a cool and dry place.
Disinfect the case weekly by soaking in just-boiled water for 10 minutes.
Replace case every three months.
Disposable contact lenses must not be used beyond their recommended disposal period.
Do not wet your lens with saliva, bottled water or tap water.
Remove the contact lens whenever you feel discomfort or redness and seek advice from your optometrists or ophthalmologists (eye doctors).
Seek medical advice from your doctor promptly if symptoms persist despite contact lens is off.

Parker & Waichman, LLP Announces It Has Filed Suit on Behalf of Man Diagnosed With Fusarium Keratitis in Left Eye After Using ReNu With MoistureLoc Contact Lens Solution - BOL

Wed, 24 May 2006 00:00:00 -0700

Parker & Waichman, LLP (http://www.yourlawyer.com) announces that it has filed a suit against Bausch & Lomb, Inc. (NYSE:BOL) on behalf of a 53-year-old man who was diagnosed with Fusarium keratitis in his left eye after using ReNu with MoistureLoc. As a result of the infection, the injured man underwent a corneal transplant after several invasive surgical procedures to remove the infection failed. He is currently awaiting FDA approval for an iris transplant. The suit was filed yesterday in the Supreme Court of the State of New York in Onondaga County. For more information on ReNu with MoistureLoc please visit http://www.renulawsuit.com and http://www.yourlawyer.com/topics/overview/renu_contact_solution.

On April 10, 2006 the FDA and the CDC issued public health warnings concerning serious fungal infections associated with contact lens solution use. The CDC stated that it had interviewed 30 patients suspected of having fungal keratitis. Of these 30 patients, 28 wore soft contact lenses and 26 used a Bausch & Lomb ReNu contact lens solution in the month prior to the fungal infection diagnosis. On April 13, 2006 Bausch & Lomb, Inc. recommended that consumers switch to another lens care solution and asked all retailers to remove U.S.-manufactured ReNu with MoistureLoc from their shelves. On May 2, 2006 the CDC announced that the number of confirmed fungal infections rose to 88 cases. Just three days later, on May 5, 2006, the CDC revised the number of confirmed cases to 102. On May 12, 2006 the CDC made another upward revision in the number of confirmed fungal eye infections to 122 cases.

On May 15, 2006 the FDA issued a press release stating: "Based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium, Bausch & Lomb has decided to permanently remove the ReNu with MoistureLoc product worldwide." The recall followed Bausch & Lomb's conclusion that the product's formula may increase the risk of fungal eye infections in certain situations. Bausch & Lomb, Inc. and the FDA both acknowledged there is a problem in the chemical properties of ReNu with MoistureLoc after testing confirmed that the solution allows a polymer film to form around the Fusarium fungus, preventing the disinfectant in the product from killing the fungus.

The injured party, who resides in upstate New York, was diagnosed with a fungal infection in his left eye in October 2005, and was referred to a cornea specialist at Columbia Presbyterian in New York City. The specialist performed a corneal confocal microscope exam and several biopsies, which confirmed the diagnosis of Fusarium keratitis. The specialist notified the plaintiff that a cornea transplant would be necessary. Because the transplant procedure could not be performed until the infection was under control, the victim was prescribed voriconazole, a potent anti-fungal medication, which had to be administered approximately every 2 hours, 24 hours each day, over the course of several months. After the infection appeared to be under control, the cornea transplant procedure was performed. During the cornea transplant surgery, additional signs of the fungal infection were discovered. This later led to approximately 5 flush-out surgeries, which involved accessing the back of the left eye through an incision in order to remove additional evidence of the Fusarium fungal infection. The infection returned following the flush-out surgeries, requiring the victim to undergo a lengthy and invasive surgery with the following procedures performed on his left eye: lensectomy, capsulectomy, removal of the iris, removal of vitreous fluid, and removal of the fungal infection. The victim is left with only 15% vision in his left eye and is currently awaiting FDA approval for an iris transplant.

Fungal keratitis is a severe infection of the cornea. Risk factors for infection usually include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiencies, and, rarely, contact lens use. An estimated 30 million persons in the United States wear soft contact lenses; the annual incidence of microbial keratitis is estimated to be 4-21 per 10,000 soft contact lens users. Fungal keratitis is a condition more prevalent in warm climates. First-line treatment includes topical and oral antifungal medications. Patients who do not respond to medical treatment usually require surgical intervention, including corneal transplantation. These infections are not transmitted from person to person.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. Parker & Waichman, LLP was the first law firm nationwide to file a class action on behalf of victims of ReNu with MoistureLoc. The class action seeks, among other remedies, a medical monitoring fund to enable consumers to obtain medical screening and treatment services. In addition to ReNu with MoistureLoc, Parker & Waichman, LLP is currently representing victims of Zyprexa, Ortho Evra Patch, Ketek, Tequin, Guidant Defibrillators, Mirapex and other defective medications and medical devices. For more information on Parker & Waichman, LLP please visit: http://www.yourlawyer.com or call (800) LAW-INFO ((800) 529-4636).

More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca

CONTACT: Parker & Waichman, LLP
          Jason Mark, Esq.
          Melanie H. Muhlstock, Esq.
          1-800-LAW-INFO
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South Africa: Dangerous eye product banned

Tue, 23 May 2006 00:00:00 -0700

Bausch & Lomb has announced that South African consumers should not be concerned because the product, ReNu with MoistureLoc, is not available in the country.

ReNu with MoistureLoc solution is a product used for the daily cleaning and disinfection of contact lenses. Bausch & Lomb stopped the shipment of this product overseas because it was linked to reports of an eye infection called Fusarium keratitis.

“This product does not cause blindness but can develop symptoms that can lead to blindness,” said Hugo van Zyl, the Bausch & Lomb country manager.

According to Van Zyl there are 5 million people worldwide using this product and 160 cases have been reported of people with symptoms that could lead to blindness.

Cases of this infection have been reported in Hong Kong, Singapore and the United States. These people had been found using ReNu with MoistureLoc solution.

Bausch & Lomb claims that it has never sold this product in South Africa and said that ingredients and preservatives in the products currently available in the country are not the same as those in MoistureLoc.

The products sold locally include ReNu MultiPlus and ReNu Multi Purpose solutions. Bausch & Lomb said it has never conducted local trials with the infectious product.

Fusarium keratitis is a fungal eye infection that can scar the part of the eye called the cornea and can lead to blindness if it is not treated properly.

Lens inventor warns of eye infection risk

Tue, 23 May 2006 00:00:00 -0700

The man who invented the daily disposable contact lens has warned that anyone who uses a solution to clean their lenses is at risk of serious eye infections.

The warning comes after a contact lens solution used by millions of people worldwide was withdrawn from sale over fears that it could cause blindness.
Living.scotsman.com MPU

Ron Hamilton, from Bruntsfield, Edinburgh, today said the risk was not isolated to one type of lens cleaning solution.

He said: "What happens is the bacteria builds up in the cleaning cases because when you put in your modern solutions it doesn't kill all the bacteria.

"If you are asking me if cleaning solutions are dangerous then I would say yes they are, in varying degrees. Some people get by quite adequately with it while others, from time to time, will encounter problems."

One brand of lens cleaner, called Renu with MoistureLoc, was withdrawn from the market this week after its manufacturer admitted the product was linked with a rare fungal eye infection.

The Renu cleaner, made by pharmaceutical giant Bausch & Lomb, was withdrawn after 122 cases of keratitis, a rare fungal infection, were confirmed in the United States. Many of those infected had used the Renu solution.

Singapore criticizes Bausch & Lomb on recall timing: NYT

Sun, 21 May 2006 00:00:00 -0700

Singapore officials are openly criticizing Bausch & Lomb Inc. (BOL) for not acting faster to recall a contact lens cleaner connected to a spate of potentially blinding infections, The New York Times reported in Monday editions.

The officials criticized the company for being slow to recall the solution even after their own research yielded what they said was compelling evidence of a link between the MoistureLoc solution and infections, the report said.

"It's hard to run away from" the evidence of a problem, said Dr. K Satku, director of medical services at the Ministry of Health. "There are too many things happening here, too many things to be coincidental."

Singapore health officials three months ago established a strong statistical connection between Bausch & Lomb's ReNu With MoistureLoc cleaner and Fusarium eye fungus infections, the Times said.

Bausch & Lomb recalled a contact lens cleaner from markets worldwide a week ago, saying that it had found a link between the product and the infection.

Fallout from outbreak of severe eye infections hits Bausch & Lomb hard

Fri, 19 May 2006 00:00:00 -0700

Bausch & Lomb Inc. made a big blunder when federal regulators revealed in April they were investigating links between its new-formula contact lens cleaner and a rare fungal infection known to cause blindness: It waited three days before withdrawing ReNu with MoistureLoc from the U.S. market.

"If there was something we could go back and change, that would be it," said company spokeswoman Meg Graham. "There isn't a handbook you can go to that tells you exactly what to do here."

Five weeks later, the eye-care product maker's campaign to shore up the reputation of its battered lens care business is under way MoistureLoc was permanently recalled from markets around the world Monday. But management and financial analysts wonder if it acted too defensively for too long to deflect lasting damage.

"It's a terrible mistake for a company in crisis not to respond in a timely way," said Howard Rubenstein of Rubenstein Associates, a public relations agency in New York whose crisis-management clients have included Christie's International PLC and Cooper Tire & Rubber Co.

"Americans and the world have short memories about stuff like this provided it isn't mishandled," echoed Hayes Roth, chief marketing officer for Landor Associates, a brand consulting firm based in San Francisco. "If they don't protect the credibility of the Bausch & Lomb brand overall so that is is unassailable as Tylenol became unassailable they will never recover."

Johnson & Johnson's aggressive and very open response to a fatal 1982 tampering scare in Chicago it promptly pulled 22 million bottles of Tylenol pain-reliever tablets from stores nationwide and introduced tamperproof packaging is considered a classic case study in how best to handle a product-liability crisis.

Bausch & Lomb's ordeal, while less horrifying, sent ripples of anxiety and confusion through the nation's 30 million lens wearers that were magnified by its hesitation in removing MoistureLoc from store shelves.

While it voluntarily suspended U.S. shipments April 10 when the Centers of Disease Control and Prevention revealed an unusual incidence of the fungal infections in Americans using MoistureLoc, it didn't withdraw the product from sale until April 13 by which time retailers led by Wal-Mart Stores were already doing so.

After a month of exhaustive testing, the company issued a worldwide recall Monday, acknowledging for the first time that its $100 million-a-year solution appeared to be the "root cause" behind an unusual spike in Fusarium keratitis infections in U.S. and Asian markets supplied from its factory in Greenville, S.C.

At last count, the CDC said about two-thirds of 122 confirmed cases of the infection in the United States involved lens wearers who reported using MoistureLoc and their medical outcomes are often unnerving.

Without prompt diagnosis and treatment typically, eye drops must be administered for up to three months the fungus can scar the cornea and cause blindness. Scores of victims have undergone corneal transplants to restore their vision, and a flurry of lawsuits could wind up costing the company anywhere from $500 million to $1 billion in damages, analyst David Maris of Banc of America Securities estimated.

The outbreak first surfaced in the Far East, leading to a halt in sales in Singapore and Hong Kong on Feb. 18 that Bausch & Lomb did not disclose in the United States until after cornea specialists began noticing a jump in infections here in March.

The incremental steps in dealing with the outbreaks have rebounded badly. In the last two months, the company's stock has plunged 30 percent and its No. 1 spot in the domestic lens care market has come under assault from chief rivals led by Alcon Inc.

The maker of contact lenses, ophthalmic drugs and vision-correction surgical instruments had a 43 percent share of lens care sales among U.S. retailers in March versus Alcon's 41 percent, said Chris Cooley, an analyst with FTN Midwest Securities in Cleveland. But a survey of optometrists indicated its share had tumbled to 26 percent by mid-May while Alcon's shot up to 60 percent, Cooley said.

Lens care has generated more than $500 million, or 23 percent, of Bausch & Lomb's sales and an even bigger slice of profits. More worrisome, Cooley said, could be the long-term effect on its older, more widely used ReNu with MultiPlus solution.

"I don't think consumer concern will be relegated solely to the MoistureLoc brand, which obviously is now defunct," he said.

Other investors, however, think that assertions by Chief Executive Ronald Zarrella that the contamination problem is restricted to MoistureLoc's unique makeup could haul the 153-year-old company out of the doldrums. Tests showed that polymers in MoistureLoc can create a film on lenses that shield the fungus from the solution's sterilizing agents.

"Bausch & Lomb's top priority is the safety of our customers," Zarrella said Monday in launching a television and newspaper advertising blitz aimed at stepping up marketing of the MultiPlus brand.

The stock has rebounded 10 percent this week, reflecting investors' hopes that the medical mystery has been solved and efforts can begin in earnest to put the problem to rest.

"It's the first step into the recovery stage, trying to salvage the brand and minimize the damage to their other product lines," said analyst Steve Hamill of Piper Jaffray.

While Roth sympathized with the difficulty of handling a public-safety emergency "there's a state of semi-chaos when something like this happens and it's very hard to imagine being in the middle of it" he underscored the need for Bausch & Lomb to be totally transparent with the public.

"It's the resisting, the defensiveness that in the end doesn't get you anywhere," he said. "They have everything to gain by not taking half-measures and by doing the responsible thing, whatever that is. The brand will live on, beyond products, beyond formulas."

Regaining consumer trust comes down to "taking steps that are counter to your own seeming economic interests," Rubenstein said.

"If it looks like they're more concerned with the consumer than they are with their bottom line, they'll come off much better," he said. "I would take this bad experience and say 'we recognized it, we dealt with it, we're protecting the public.' In other words, don't make believe it didn't happen."

Eye infections in state lead to investigation

Fri, 19 May 2006 00:00:00 -0700

Two Missouri cases of an aggressive fungal eye infection associated with the use of contact lenses are under investigation.

The Centers for Disease Control and Prevention has released information indicating 122 confirmed cases of Fusarium keratitis, 15 possible cases and 60 cases that are still under investigation, including the two from Missouri. The eye infection is now in 33 states and may be affecting more than 200 people, according to the Centers for Disease Control and Prevention. Additional data released by the center has also confirmed that five types of contact lens solution were used by people suffering from Fusarium keratitis.

“There are a lot of confused contact lens wearers out there, and we are aggressively reaching out to them,” Cory Ridenhour, executive director of the Missouri Optometric Association, said. “While we realize the importance of due diligence throughout this investigation process, we are hoping for a swift, definitive conclusion from federal health officials to ease patient concerns and minimize further risk.”

In efforts to minimize further risk, Bausch & Lomb asked retailers to remove its ReNu with MoistureLoc brand contact lens solution in Missouri, as well as the rest of the country. However, 28 patients who have contracted the infection have told investigators they used ReNu MultiPlus or an unspecified ReNu solution.

Dr. David Falkenhain, O.D., of Falkenhain Eye Group in Rolla, said the Bausch & Lomb contact solution isn’t the only one that may be linked to the eye infection, but it is the one the most Fusarium keratitis cases have been associated with.

“We still don’t know what brought on the Fusarium keratitis cases, but Bausch & Lomb did take their MoistureLoc brand off the market since that was the one that seemed to have the most Fusarium keratitis cases associated with it.”

Health authorities in Europe, Singapore, Hong Kong and Malaysia are investigating similar cases. Investigators in Singapore have also found a strong association between the eye infections and the use of Bausch & Lomb solutions.

Fusarium keratitis is similar to Pink Eye infections, according to Falkenhain.

“It’s actually a form of Pink Eye,” he said. “It’s painful, so you’ll know there’s something wrong if you have it.”

Falkenhain said Fusarium keratitis is treatable if it’s diagnosed, but could cause serious problems if it goes untreated.

“If it goes untreated it could cause some serious eye problems, but otherwise there are topical eye drops to control it,” he said.

Falkenhain, along with other optometry doctors in Missouri, want to remind people that only slightly more than 200 cases of the eye infection have been reported compared to the more than 30 million Americans who wear contact lenses.

“There was actually only a very small number of cases,” Falkenhain said.

Even still, Missouri optomtery doctors are educating patients about the difference among contact lens care solutions. Most solutions are approved for use without rubbing when disinfected, according to the Missouri Optometric Association. However, optometrists are recommending that all patients rub and then rinse their lenses according to package instructions for additional safety. Regardless of which cleaning or disinfecting solution consumers use, contact lens wearers should take extra precautions with lens hygiene habits to help lower their chances of infection.

To guard against infection, Falkenhain recommends contact wearers always wash their hands before handling contact lenses. Replacing contact cases every six months is also important. Although many of the newer contracts are OK to sleep in, Falkenhain recommends people don’t sleep in their contacts.

“Washing your hands, replacing the contact case and not sleeping in your contacts are all important,” he said. “The main thing is to be clean about it. If you do notice any problems, get your contacts out and get to an eye doctor.”

Although Falkenhain hasn’t seen any cases of Fusarium keratitis in his practice, he said he’ll be watching for it just in case.

“I’ve been watching for it, but luckily I haven’t seen any cases,” he said. “And I’ve also pulled the MoistureLoc off my shelves, so that’s about all I can do.”

Reducing your risk of infection:

Always wash your hands before handling contact lenses.
Carefully and regularly clean contact lenses as directed by your optometrist. If recommended, rub the contact lenses with fingers and rinse thoroughly before soaking lenses overnight in sufficient multi-purpose solution to completely cover the lens.
Store lenses in the proper lens storage case and replace the case every three months. Clean the case after each use, and keep it open and dry between cleanings.
Use only products recommended by your optometrist to clean and disinfect your lenses. Saline solution and rewetting drops are not designed to disinfect lenses.
Only fresh solution should be used to clean and store contact lenses. Never re-use old recommendations, even if the lenses are not used daily.
Replace your lenses on schedule as directed by your optometrist.

When wearing or cleaning contacts:

Never put contact lenses in the mouth or moisten them with saliva, which is full of bacteria and a potential source of infection.
Don’t use tap water or homemade saline solutions. Improper use of solutions has been linked to a potentially blinding condition among soft lens wearers.
Never use contacts that have not been prescribed by an eye doctor. Contact lens wear is not an option for everyone; consult with an optometrist to see if contact lenses are an appropriate choice for vision correction.

Doctors remind patients to be aware of the signs of infection and urge anyone who experiences the following symptoms to contact their optometrist immediately:

Red and irritated eyes lasting for an unusually long period of time after lens removal
Pain in and around the eyes, especially if it progressively worsens
Increased sensitivity to light
Sudden blurred or fuzzy vision
Excessive eye tearing of discharge

Local doctors return cases of soft contact lens solution

Thu, 18 May 2006 00:00:00 -0700

A potentially blinding eye infection has been spreading among wearers of soft contact lenses, prompting lens maker Bausch & Lomb to pull one of its many brands of lens-care solution from store shelves and local users to question their doctors.

Contact wearers were told last month to stop using ReNu with MoistureLoc, and local optometrists and ophthalmologists have returned cases upon cases of the product, which was voluntarily recalled worldwide by Bausch & Lomb on Monday.

"We just sent back all of the cases that were recently distributed to us," said Dr. Robert V. Serych, an optometrist at Dr. Serych and Associates at the Beaver Valley Mall.

The federal Food and Drug Administration and the Centers for Disease Control and Prevention, which are conducting a joint investigation, have been inspecting the company's plant in Greenville, S.C., but haven't turned up any evidence of contamination, although testing is ongoing and results could take weeks.

Last month, the agencies began alerting health-care professionals and their patients who wear soft lenses that nationwide reports of Fusarium keratitis, a rare but serious fungal eye infection that can cause blindness, were increasing.

Health authorities have confirmed more than 100 cases of the infection, which for some patients has caused significant vision loss that resulted in the need for corneal transplants. The CDC has cautioned that not all of the infections involve Bausch & Lomb exclusively. Three cases involved Alcon solutions, and another three were linked to Advanced Medical Optics solutions.

Serych said none of his patients have been affected by the fungal infection, but in the last two to three weeks, many have been asking questions.

"To my knowledge, there have been no reported cases of this fungus in our area, in the Pittsburgh area, which is fortunate," Serych said.

His office has advised patients to dispose of the MoistureLoc solution if they have it. Patients have been given samples of comparable solutions in their place, he said.

In a statement from Bausch & Lomb, and in a commercial aired by the company, officials say that the product will not be reintroduced to the market and that former users can try ReNu MultiPlus or ReNu Multi-Purpose brands.

Serych said there haven't been any final conclusions that Bausch & Lomb's solution is contaminated.

"This just happens to be one of many solutions that patients of this fungus have identified using at one point. This could all be for nothing. They have no idea," Serych said.

Contact lens solution withdrawn

Wed, 17 May 2006 00:00:00 -0700

A popular contact lens solution has been withdrawn voluntarily from the market as a result of a link between using the solution and developing an eye infection.

Bausch and Lomb have withdrawn ReNU with MoistureLoc Multi-Purpose from the worldwide market following an investigation by the company which led them to suspect that a certain aspect of the formula for the solution may increase the relative risk of the infection Fusarium keratitis.

According to the Irish Medicines Board, to date there have been no confirmed reported incidents of this infection in Ireland. There have, however, been reported cases in the US.

The recall applies to all batches of Bausch and Lomb manufactured ReNu with MoiustureLoc MultiPurpose solution currently on the Irish market, and customers are advised to switch to an alternative contact lens solution.

The Medicines Board says contact lens wearers should immediately stop using the ReNu with MoistureLoc solution and return the bottle to their eyecare practitioner/optician to exchange it for an alternative lens care solution.

It says people who have been using the withdrawn product should consult their eyecare professional/optician concerning the use of an appropriate alternative cleaning/disinfectant product.

Federal inspectors criticize Bausch & Lomb

Wed, 17 May 2006 00:00:00 -0700

The Bausch & Lomb contact lens solution being recalled worldwide and linked to an outbreak of serious eye infections was put on the market without being fully tested for effectiveness in killing bacteria and fungus, according to an inspection report by the U.S. Food and Drug Administration.

ReNu with MoistureLoc, used by 2.3 million Americans, never went through a full FDA approval process, the report indicates, and the company's new-product design team failed to complete a wide range of tests both before and after it was sold to consumers.

After its introduction, as complaints came in that the product could be linked to a spike in cases of rare fungal infections, the company failed to quickly notify the FDA, as required by law, according to the report released Tuesday of inspectors' observations at Bausch & Lomb's lens solution plant in Greenville, S.C.

FDA and Bausch & Lomb officials said they don't think any of the eight pages of problems cited in the report contributed to the worldwide outbreak of fusarium keratitis, a potentially blinding eye infection caused by a common fungus.

But a consumer advocacy group found the report troubling.

"It looks like at almost every step of the way the company was sloppy, careless, and the safeguards that were supposed to be in place were ignored," said Diana Zuckerman, president of the National Research Center for Women & Families, which specializes in medical product safety issues.

The company on Monday announced it is permanently pulling ReNu with MoistureLoc from the market worldwide because it appears the formula allows the fungus to grow when consumers aren't careful in their care and storage of lenses.

Steven Niedelman, the FDA's deputy associate commissioner for regulatory affairs, cautioned that the report is preliminary and based on the inspectors' observations inside the plant. Now higher-ranking FDA officials will examine the report to determine whether documents back up those observations.

"We're going to be very carefully assessing this report," Niedelman said. "If action needs to be taken, we'll take those actions that are appropriate."

Bausch & Lomb officials would not answer specific questions about the FDA report. In a written statement, the company said it communicated promptly with the agency about fusarium infections and that it is taking appropriate corrective actions for other issues cited at the plant.

The South Carolina plant is the sole maker of all Bausch & Lomb contact solutions sold in North America and most of Asia.

Prior to this inspection, which occurred between March 22 and May 15, the FDA hadn't inspected the plant in three years. Indeed, the agency allowed the company to go into production with the new MoistureLoc product in 2004 without any inspection to validate the manufacturing practices, according to the new report and interviews with FDA officials.

Contacts and their solutions are considered medical devices and are regulated by the FDA.

Tim Ulatoski, the FDA's compliance director in its center for devices, said Monday the agency will be looking into why there wasn't an inspection at the time of the new product launch

"We're taking a look at the history there and actually how the process rolled out," he said. "I can't give you a firm statement or conclusion" about whether the FDA should have done an inspection prior to the MoistureLoc product launch.

By statute, the FDA is supposed to inspect all plants at least once every two years, but it rarely does. While a new product launch might trigger an inspection, it doesn't always, agency officials said.

The plant was cited for "significant" lapses in manufacturing processes in May and June 2002, including concerns about the appropriate amounts of preservative/disinfectant in eye care products and flaking ceiling paint chips in product-filling rooms, according to the document.

After a March 2003 reinspection found the problems were fixed, the FDA didn't visit the plant again until it began investigating the fusarium outbreak this March.

FDA: Reports on eye infection were delayed

Wed, 17 May 2006 00:00:00 -0700

U.S. drug regulators claim Bausch & Lomb delayed informing them about reports linking its contact-lens solution to a rare eye infection.

The Wall Street Journal reported the Food and Drug Administration on its Web site said that Bausch & Lomb, which has headquarters in Rochester, N.Y., didn't initially tell the agency of reports the lens solution may be causing cases of Fusarium keratitis, an eye infection.

Earlier this week, the company announced a world-wide recall of the solution ReNu with MoistureLoc, which was being manufactured at its Greenville, S.C., plant, the Journal reported.

A Bausch & Lomb spokeswoman said the company "communicated promptly and directly with the agency regarding reports the company received about Fusarium infections."

Her statement said the company is working to take "immediate, appropriate corrective actions" to address the concerns raised in the FDA inspection, the Journal reported.

Company permanently removes solution linked to infections

Tue, 16 May 2006 00:00:00 -0700

Bausch & Lomb Inc. said Monday it has permanently removed from markets worldwide a contact-lens solution linked by health authorities to an outbreak of rare fungal infections that can cause blindness. Its shares rose nearly 9 percent.

‘‘Bausch & Lomb’s top priority is the safety of our customers, and we want them to have complete confidence in our products,’’ said the eye-care product maker’s chief executive, Ronald Zarrella.

The Food and Drug Administration said Bausch & Lomb suspects that ReNu with MoistureLoc solution’s unique disinfecting and moisturizing agents ‘‘in certain unusual circumstances can increase the risk of Fusarium infection.’’

‘‘While FDA is still concluding its scientific evaluations at this time we recognize that Bausch & Lomb has proposed the formulation as the potential root cause of the increased relative risk of Fusarium keratitis associated with use of the ReNu with MoistureLoc product,’’ the agency said in a statement.

‘‘There does appear to be an association between the formulation itself as well as certain use patterns in creating this higher-than-normal incidence of these particular infections,’’Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, said in a conference call with reporters.

Schultz did not elaborate on ‘‘use patterns’’ other than to say they combined ‘‘somewhat unique circumstances.’’
‘‘At this point, our scientific conclusion is pretty clear that the association is in fact just with the MoistureLoc solution,’’ Schultz said.

The Centers for Disease Control and Prevention said Friday that the number of confirmed cases of Fusarium keratitis in the United States has climbed to 122, most of them contact-lens wearers who reported using Bausch & Lomb’s newest cleaner, which was introduced in late 2004.

The company halted U.S. sales of MoistureLoc on April 13 after the CDC said it was investigating an unusual spike in infections in Americans using the product. The outbreak first surfaced in the Far East in the fall and infections have showed up most recently among contact-lens wearers in Europe.

The fungus is commonly found in plant material and soil in tropical and subtropical areas. Without eye-drop treatment, which can last two to three months, the infection can scar the cornea and blind its victims. At least eight U.S. patients have required cornea transplants.

Extensive federal inspections of its factory in Greenville, S.C., where MoistureLoc was made for U.S. and several Asian markets, have not turned up evidence of ‘‘contamination, tampering, counterfeiting or sterility failure,’’ Zarrella said in a statement.

Bausch & Lomb recalls, discontinues contact lens solution

Tue, 16 May 2006 00:00:00 -0700

Bausch & Lomb Inc. said Monday it would no longer make its ReNu with MoistureLoc contact-lens solution and was recalling the product worldwide after linking certain uses to a potentially blinding eye infection.

The company decided to remove the solution from store shelves after 122 patients in 26 states developed the rare infections caused by a commonly occurring fungus that inflames the cornea.

After months of investigation in cooperation with federal health officials and regulators, Bausch & Lomb concluded that infections from the solution developed in combination with certain customer habits, such as leaving the bottle open, letting the solution evaporate in the lens case or allowing the lens case to dry without washing it first.

"We believe that these infections may involve a perfect storm of factors," said Ronald Zarrella, chairman and CEO of the Rochester, N.Y.-based company in a conference call with Wall Street analysts.

Federal health officials first learned of the problem March 8, when a New Jersey ophthalmologist reported three cases to the Centers for Disease Control and Prevention in Atlanta. Retailers stopped selling the solution.

Last month, the company stopped shipping batches made at its Greenville, S.C., plant and then asked retailers to remove any on their shelves.

Bausch & Lomb took the latest and most drastic step after determining the product's formula was partly responsible for the spike in infections, which have also been reported in Hong Kong and Singapore.

After polymers in the solution are exposed to air, a film develops and the fungus prevalent in bathroom sinks can adhere to it, Zarrella said.

The outbreak "appears to be related to the design of this particular solution and the way in which it is used," said Dr. Daniel Schultz, director of the Food and Drug Administration's device center.

Schultz said FDA inspectors found some problems at the Bausch & Lomb plant in Greenville that manufactured the contact lens solution but did not believe they played a role in the higher incidence of eye infections among users.

Zarrella said Bausch & Lomb has already fixed many of the problems identified by inspectors.

Introduced in late 2004, ReNu with MoistureLoc was used by 2.3 million Americans and 5 million consumers worldwide and had $100 million in sales last year.

Zarrella estimated the recall will cost $50 million to $70 million.

The company urged contact lens wearers to wash their hands, change their lenses and lens cases, clean out the cases and always use new solution each time they clean their lenses.

Contact lens maker pulls solution

Tue, 16 May 2006 00:00:00 -0700

A popular contact lens cleaning solution was pulled from retail shelves Monday in connection with a far-reaching outbreak of fungal eye infections known to cause blindness.

Bausch and Lomb’s ReNu with Moisture-Loc contact lens solution is currently under investigation by the Food and Drug Administration and the Center for Disease Control in conjunction with its ability to harbor fusarium, a fungus that is commonly found in organic matter such as soil and plants.

The company suspended U.S. sales of the product following a CDC investigation announced April 10.

Sales have been suspended in the Far East since Feb. 18, following outbreaks in Singapore, Hong Kong and Malaysia.

“Bausch & Lomb’s top priority is the safety of our customers, and we want them to have complete confidence in our products,” the eye-care product maker’s chief executive, Ronald Zarrella said in a press release.

Fusarium keratitis is a fungal infection of the eye that, if left untreated, can lead to scarring of the cornea and eventually blindness.

The CDC has reported that this infection cannot be transmitted from person to person. People who have trauma to the eye, certain eye diseases and problems with their immune system may be at increased risk for these types of infection.

The rise in infections has brought about a variety of lawsuits with many of its victims having to undergo corneal transplants. The probability of the host rejecting the transplanted eye is higher than 80 percent.

The CDC has confirmed 122 cases of fusarium keratitis in the U.S., with 15 possible cases and another 60 being investigated. Cases have been confirmed or are being investigated in 33 states.

More than half of the confirmed cases involved use of B&L’s ReNu with Moisture-Loc contact lens solution.

About a third of the cases involved any of the other ReNu products and less than 10 percent of the cases involved Advanced Medical Optics and Alcon products.

Around 30 million Americans wear contact lenses, with about 2.3 million of them using the ReNu with Moisture-Loc solution. Another 11 million use the MultiPlus solution. The Moisture-Loc solution, released in late 2004, contributed to roughly $45 million in global sales last year.

Some eye-care experts have theorized that Alexidine, the new disinfecting agent used in the Moisture-Loc solution, in conjunction with poor hygiene habits can lead to an outbreak of the infection.

In response to the rising concerns, the FDA has joined forces with the CDC and has been inspecting the Bausch & Lomb plant and facilities in Greenville, S.C. since March 22.

Extensive federal inspections of the factory where Moisture-Loc was made for U.S. and several Asian markets have not turned up evidence of “contamination, tampering, counterfeiting or sterility failure,” said Zarrella.

“This is a serious infection and soft contact lens users should be mindful of the potential to develop this problem,” said Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health.

Healthcare providers have been urged to stop using all ReNu products and to advise their patients to do the same.

Contact lens wearers are encouraged to consult their eye-care provider to find an alternative product and to employ the “rub and rinse” technique to clean their contacts rather than the no-rub method.

In the event of symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling with the use of contact lenses, contact your eye-care professional immediately.

Bausch & Lomb also makes contact lenses, ophthalmic drugs and vision-correction surgical instruments, generates more than $2 billion in annual revenues and employs 12,400 people.

Fusarium Fungus Bausch Lomb Renu Eye Infection Lawyer

Tue, 16 May 2006 00:00:00 -0700

Fusarium Fungus

Fusarium fungus is regularly found in plant material and soil in tropical and subtropical areas. Without eye drop treatment, which can last two to three months, the infection can scar the cornea causing blindness. Symptoms may include blurry vision, pain or redness, increased sensitivity to light and excessive discharge from the eye.

Bausch & Lomb voluntarily suspended shipment of a contact lens solution after federal health officials linked it on April 10, 2006 to a fungal eye infection that can cause temporary blindness. Federal and state health officials have interviewed 30 of those patients. Of the 28 who wore soft contact lens, 26 reported using Bausch & Lomb's ReNu brand contact lens solution. The U.S. Centers for Disease Control and Prevention is watching the situation and said it has received reports of about 50 possible cases in 12 states this year so far.

The 109 U.S. cases the CDC is investigating involve infections from June 2005 to March and are from California, Connecticut, Florida, Georgia, Iowa, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Dakota, Ohio, Pennsylvania, Tennessee, Texas and Vermont.

Singapore health officials noticed a spike in January and discovered 39 cases involving contact lens users from 2005 to February of this year. Cases have also been reported in Malaysia and Hong Kong.

To complicate matters further, the fungus is tricky to detect because diagnosis requires a lab culture not all doctors are prepared to take or read. And the fungus can be so slow-growing that it takes weeks for the culture to come back. The medicine used to treat fungal infections is not widely stocked by pharmacies and often must be ordered.

If you or a loved one wears contact lenses and you developed Fusarium fungus or any other injury as a result of Bausch & Lomb Renu MoistureLoc saline solution, contact Parker & Waichman, LLP for a free case evaluation. Call 1-800-LAW-INFO (1-800-529-4636) or fill out the short form at the right.

Yourlawyer.com (Fusarium Fungus News)

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