Yourlawyer.com (Complete MoisturePlus News)

Recalled Complete MoisturePlus Contact Lens Solution Still on Store Shelves, In Homes

Thu, 02 Aug 2007 00:00:00 -0700

Recalled Complete MoisturePlus Multipurpose Contact Lens Solution is still on some store shelves, and word of the recall has been slow to reach consumers. As a result, the Food and Drug Administration (FDA) is concerned that many are still using the product. The contact lens solution, which was manufactured by Advanced Medical Optics, was recalled this past May after it was linked to several severe eye infections.

In May, the Centers for Disease Control (CDC) linked four cases of Acanthamoeba Keratitis (AK) to Complete MoisturePlus Contact Lens Solution. AK is a rare, but severe, parasitic eye infection that sometimes plagues soft contact lens users. Generally, the disease only affects 2 out of every one million users, but during its investigation of Complete MoisturePlus, the CDC found that users of the solution were seven times more likely to develop AK. The symptoms of AK are similar to other more common eye infections, and include eye pain or redness, blurred vision, light sensitivity and excessive tearing. However, AK is difficult to treat, and can lead to vision loss, and the need for a corneal transplant.

On Wednesday, the FDA issued a reminder to contact lens users to dispose of any Complete MoisturePlus Multipurpose Contact Lens Solution that might be in their possession. Complete MoisturePlus users were also reminded to replace their contact lenses if they were treated with the solution, and to replace their lens containers as well.

The FDA also demanded that Advanced Medical Optics do more to facilitate the recall. The FDA said that far fewer bottles of Complete MoisturePlus were returned than was expected, and that it had found the solution on the shelves of several stores. The FDA would like to see more advertisements of the recall. Though there was a burst of media attention given to the recall in May, it has since waned. For its part, Advanced Medical Optics said that it had employed a broad based media campaign, including press releases and mailings to doctors, to publicize the recall. The company has no plans to advertise at this time.

The Complete MoisturePlus recall is similar to another recall of contact lens solution in May 2006. At that time, Bausch & Lomb’s Renu with MoistureLoc was linked to an outbreak of Fusarium Keratitis, another rare eye infection that had the potential to cause blindness. The CDC said that those infected with Fusarium Keratitis were 20 time more likely to have used the MoistureLoc solution. The CDC reported that the MoistureLoc contact lens solution appeared to have poor disinfectant qualities.

In the case of the Complete MoisturePlus recall, the FDA is urging anyone with symptoms similar to AK to seek medical attention immediately, especially if they used Complete MoisturePlus recently.

Doctors, Health Officials Confused By Latest Contact Lens Infections

Tue, 29 May 2007 00:00:00 -0700

Acanthamoeba keratitis a potentially blinding eye infection caused scrambling doctors and health officials this weekend to try and find out the reason for the outbreak which resembles a similar one that took place last year. Complete MoisturePlus manufactured by Advanced Medical Optics (AMO) has been pulled from store shelves as a result of the outbreak. The product markets itself as the “The first and only multi-purpose solution that contains two-tear like moisturizers, beneficial electrolytes and taurine.”

The Centers for Disease Control and Prevention (CDC), in concert with the Food and Drug Administration, state and other partners, has identified the outbreak called Acanthamoeba keratitis (AK). This infection is caused by a free-living ameba (Acanthamoeba) which is a microscopic organism found everywhere in nature. Infections can result in permanent visual impairment or blindness. AK primarily affects otherwise healthy people, most of whom wear contact lenses. In the United States, an estimated 85% of cases of this infection occur in contact lens users. The incidence of the disease in the U.S. is approximately one to two cases per million contact lens users.

CDC has received reports of 138 cases of culture-confirmed AK in 35 states and Puerto Rico. Thirty-nine of the 46 case-patients wore soft contact lenses. Preliminary information obtained by CDC from patient interviews indicates that, among soft contact lens users who reported the use of any type of solution, 21 (58%) reported having used Advanced Medical Optics (AMO) CompleteR MoisturePlusTM Multi-Purpose Solution in the month prior to symptom onset. Out of the 37 case-patients for whom clinical data was available, 9 (24%) failed medical therapy and required or are expected to undergo corneal transplantation.

People who wear soft contact lenses and who use Advanced Medical Optics (AMO) CompleteR MoisturePlusTM Multi-Purpose Solution are advised to:

Stop using the product immediately and discard all remaining solution including partially used or unopened bottles. Choose an alternative contact lens solution.
Discard current lens storage container.
Discard current pair of soft lenses
See a health care provider if experiencing any signs of eye infection: Eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye, or excessive tearing.

Acanthamoeba keratitis is caused by a parasite, can be difficult to detect and is hard to treat. This outbreak has involved at least 138 patients.

The outbreak last year was linked to a different manufacturer’s lens solution and a different microbe. In both instances, the cornea, the eye’s transparent outer covering, is at risk. But why two different microbes caused the outbreaks is not known at this time.

Last year, the outbreak of fusarium keratitis was caused by a fungus; there were 164 confirmed cases. It was linked to ReNu With MoistureLoc made by Bausch & Lomb, but how the product caused the problem is unknown.

AMO said they are pulling their product and that there was no evidence to suggest that its product was contaminated with acanthamoeba.

CDC warns about contact lens solution

Sat, 26 May 2007 00:00:00 -0700

Government officials are warning people to throw away a contact lens solution after an investigation linked it to a rare eye infection. The warning concerns AMO Complete Moisture Plus Multi-Purpose Solution, used for cleaning and storing soft contact lenses, said a spokeswoman for the U.S. Centers for Disease Control and Prevention.

The solution seems to be a factor cases of Acanthamoeba keratitis, a painful eye infection that can lead to permanent vision loss or blindness.

The CDC and the U.S. Food and Drug Administration are investigating 138 confirmed cases.

The solution is made by Advanced Medical Optics Inc., a publicly traded company based in Santa Ana, Calif. The company issued a statement Friday night saying it was "immediately and voluntarily recalling" the solution.

"There is no evidence to suggest that today's voluntary recall is related to a product contamination issue and this does not impact any of AMO's other contact lens care products," the statement said.

The confirmed infections have been reported since January 2005, the company said.

CDC officials said people should discard the solution, throw out their current contact lenses and toss the lens storage case. All of them may harbor the infecting amoeba, said Michael Beach, team leader in the CDC's division of parasitic diseases.

An estimated 85 percent of U.S. cases of Acanthamoeba keratitis occur in contact lens users, but it's extremely unusual the estimated prevalence is one to two cases per 1 million contact lens wearers. Contact lens wearers who practice proper lens care and people who don't wear contact lenses can still develop the infection.

It's hard to diagnose and treat and some of the drugs used to fight the infection are available only overseas or from compounding pharmacies.

Doctors first suspected a problem in 2004, when a University of Illinois-Chicago ophthalmologist, Dr. Elmer Tu, noticed more than a dozen cases of the infection. Normally, he might see only one or two in a year, Tu said.

UIC doctors saw 35 patients with the condition from May 2003 through September 2006. About 55 percent used the Advanced Medical Optics product exclusively, Tu said.

UIC investigators think the infection is not originating in the manufacturing process, but that the cleaning solution is not protecting people from the infection, which they get in their eyes through showering or swimming, Tu said.

The amoeba that causes the infection is naturally present in soil and water. Wearing contact lenses while swimming or in the hot tub appears to increase the risk of infection.

The cases were reported to the Illinois state health department, which notified the CDC. A CDC investigation in about 35 states led to Friday's announcement.

The solution is not marketed to protect against the amoeba. But "it's supposed to be free of any type of microorganisms. It's not supposed to result in anyone getting an infection," said Julie Zawisza, an FDA spokeswoman.

The FDA will take information from the CDC investigation and try to discern what about the solution or how people were using it could be responsible for the infection cases, she added.

Health officials have interviewed 46 patients so far. Of those, 36 wore contact lenses and used some form of solution, and 21 used the Advanced Medical Optics solution within a month of onset of symptoms, Beach said. It was a strong enough association to cause health officials to issue Friday's warning, Beach said.

Dozens of cases of this rare condition can be significant, eye experts said.

"It's a large number if it's happening to you. It's a large number if there is a little pocket of it. It's not a large number if you consider there are 35 million contact lens wearers in the United States," said Dr. William Ehlers, a University of Connecticut Health Center ophthalmologist.

The company said in its statement that consumers who believe they have the recalled solution should call (888) 899-9183. It is contacting retailers, customers and distributors on return and replacement instructions, it said.

The investigation is the second into eye infections associated with contact lens solution undertaken by the CDC and FDA in the past year. In 2006, a Bausch & Lomb multipurpose contact lens solution was linked to a fungal eye infection called Fusarium.

Advanced Medical Optics recalls contact lens solution

Wed, 22 Nov 2006 00:00:00 -0800

Eye care products maker Advanced Medical Optics Inc. is recalling U.S. batches of its Complete MoisturePlus multipurpose contact lens solution and Active Packs after finding bacterial contamination in three lots made at the same plant in China and distributed in Japan.

The Santa Ana, Calif.-based company said it has not received any reports of adverse health events associated with the 18 recalled product lots in the U.S.

Advanced Medical Optics said it withdrew affected products from the market in Japan earlier and alerted regulatory authorities worldwide including the U.S. Food and Drug Administration.

Tainted solution could cause an eye infection, the company said. It said the risk of infection is likely low but it decided to take a conservative approach.

The company cut its earnings outlook on Tuesday as it announced the recall, and its shares sank nearly 9 percent.

Earlier in the year, Bausch & Lomb conducted a recall of one of its contact lens solutions after it became associated with a severe fungal infection. In May, Bausch & Lomb decided to permanently discontinue its ReNu with MoistureLoc contact lens solution after hundreds of cases of an eye fungus were linked to the product.

Of the 2.9 million units being recalled worldwide, about 183,000 units made it into the U.S. Affected U.S. units account for less than one percent of Complete MoisturePlus' annual sales. The company booked about $208.6 million, or about 28 percent of total sales, from eye care product sales for the first nine months of 2006.

The company said it will suspend production at its plant in China for about 10 to 12 weeks.

Advanced Medical Optics Announces Voluntary Recall of 18 Lots of Complete(R) MoisturePLUS(TM) Contact Lens Care Products Distributed and Sold in the U.S.

Wed, 22 Nov 2006 00:00:00 -0800

Advanced Medical Optics, Inc. (AMO) (NYSE:EYE) , a global ophthalmic surgical and eye care products company, today announced a nationwide, voluntary recall of certain lots of its 12-ounce COMPLETE(R) MoisturePLUS(TM) multipurpose contact lens care solution and Active Packs. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at its manufacturing plant in China, AMO is recalling 18 lots distributed in the U.S. that were manufactured on the same production lines during the same production period. Non-sterility of a contact lens solution may have serious health consequences, including eye infection and microbial keratitis. AMO has not received any reports of adverse health events associated with the recalled product lots in the U.S.

Lot numbers are located on the top of the product box and on the side of the product bottle. The recalled product lots include:

Bottled Lot

Package Lot No. Product Description Number(s) in Kit
ZB03087 COMPLETE MoisturePLUS Active Pack ZB03085, ZB02845
ZB03724 COMPLETE MoisturePLUS Active Pack ZB03713, ZB03506
ZB03734 COMPLETE MoisturePLUS Active Pack ZB03713, ZB03506
ZB03735 COMPLETE MoisturePLUS Active Pack ZB03713, ZB03510
ZB03736 COMPLETE MoisturePLUS Active Pack ZB03713, ZB03510
ZB03739 COMPLETE MoisturePLUS Active Pack ZB03737, ZB03510
ZB02710 COMPLETE MoisturePLUS 12oz (360 mL) ZB02709
ZB02714 COMPLETE MoisturePLUS 12oz (360 mL) ZB02713
ZB02718 COMPLETE MoisturePLUS 12oz (360 mL) ZB02717
ZB02722 COMPLETE MoisturePLUS 12oz (360 mL) ZB02721
ZB02746 COMPLTE MoisturePLUS 2 X 12 oz ZB02745
ZB02750 COMPLETE MoisturePLUS 2 X 12 oz ZB02749
ZB02771 COMPLETE MoisturePLUS 2 X 12 oz ZB02770
ZB02792 COMPLETE MoisturePLUS 2 X 12 oz ZB02791
ZB02796 COMPLETE MoisturePLUS 2 X 12 oz ZB02795
ZB02800 COMPLETE MoisturePLUS 2 X 12 oz ZB02799
ZB02804 COMPLETE MoisturePLUS 2 X 12 oz ZB02803
ZB03535 COMPLETE MoisturePLUS 2 X 12 oz ZB03534

Contact lens users who experience symptoms of an eye infection such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling, should remove their lenses and consult their eye care provider immediately.

Consumers who believe they are in possession of the recalled product should discontinue use immediately and call 1-877-884-7779 Monday through Friday between 8 a.m. and 5 p.m. Eastern Time or visit www.amo-inc.com for instructions. The company is currently contacting retailers, customers and distributors regarding return and replacement instructions. Reply cards and mailing slips are being provided for return of product. Retailers may also call 1-877-884-7779 Monday through Friday from 8 a.m. through 5 p.m. Eastern Time for more information.

Please report any adverse reactions experienced with the use of this product and/or quality problems to AMO by calling 1-calling 1-800-347-5005 and to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

Product from the recalled lots was distributed nationwide to food, drug and mass merchandiser accounts. The recall does not include 4-ounce and 16-ounce bottles, or professional samples and packs provided to eye care practitioners.

The U.S. recall includes approximately 183,000 units, representing less than one percent of COMPLETE(R) MoisturePLUS(TM) contact lens products distributed in the U.S. on an annual basis. Based on its investigation to date, AMO believes the likelihood of users experiencing an adverse reaction is low. However, the company is taking a conservative approach and is conducting the recall in the best interest of its customers.

The company commenced the investigation after testing of products sold in Japan determined that three production lots were found to be non-sterile and contaminated with bacteria. As a result, AMO conducted a limited product withdrawal in Japan and notified appropriate global regulatory authorities, including the FDA. The subsequent investigation traced the manufacturing issue to two of the four production lines in its China facility that manufactured product during a specific period. This product was shipped to the U.S., Japan and Asia Pacific and is now the subject of this recall. AMO has temporarily ceased all manufacturing at the China facility and scheduled a special cleaning and sanitation of the manufacturing areas and all applicable equipment.

Additional information concerning these and other risk factors may be found in previous financial press releases issued by AMO and AMO's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in AMO's 2005 Form 10-K filed in March 2006 and quarterly report on Form 10-Q filed in November 2006. Copies of press releases and additional information about AMO are available at www.amo-inc.com, or by contacting AMO's Investor Relations Department by calling 714-247-8290.
Products manufactured in AMO's facility in Spain, which produces the vast majority of AMO's contact lens solution products distributed in the U.S. and Europe, are not affected by this recall.

"AMO is committed to taking all necessary measures to remedy this production-line issue and protect the trust physicians and patients place in our products," said Randy Meier, executive vice president, operations; president, global eye care and chief financial officer. "COMPLETE(R) MoisturePLUS(TM) products have been used safely by millions of contact lens wearers since their introduction in 2003 and are supported by our 50-year heritage of meeting high safety and efficacy standards."

Complete MoisturePlus Recall Lawyer Lawsuit Attorneys

Wed, 22 Nov 2006 00:00:00 -0800

Injured by Complete MoisturePlus?

AMO Complete MoisturePlus Recall
During the week of May 21, 2007, U.S. health investigators linked Complete MoisturePlus, a contact lens solution made by Advanced Medical Optics Inc., to the outbreak of a rare but serious eye infection that can cause blindness. As of May 24, 2007, in a probe that includes 35 states and Puerto Rico, the U.S. Centers for Disease Control and Prevention (CDC) identified 138 "culture-confirmed" cases and has interviewed 46 patients. Research illustrates 36 of those people wore soft contact lenses, 21 reported using Advanced Medical Optics Complete MoisturePlus Multi-Purpose a month before symptoms, and 14 used it exclusively. That was enough of a link to a product with limited market share to spark a public announcement, said Sharon Roy, medical epidemiologist with the CDC's division of parasitic diseases.

Eye infections from Acanthamoeba typically occur in contact lens wearers but are extremely rare, appearing on average in just one or two cases per million lens wearers per year. However, various eye-care centers around the U.S. have been tracking increased cases of the infection over the last three years. The CDC's interest in the recent outbreak was prompted by research done in the Chicago area at the University of Illinois at Chicago, led by Charlotte Joslin and Elmer Tu. They have tracked 67 cases of the outbreak in the Chicago area since June 2003, and had a paper on the matter accepted Friday for future publication in the American Journal of Ophthalmology.

According to Ms. Joslin, who is familiar with the CDC's plans and research, the agency was expected to announce details regarding the infections and connections to the Advanced Medical Optics solution on Friday. The findings are very similar to what the UIC study uncovered in the Chicago area -in 55% of 38 cases where researchers had complete data, the Advanced Medical Optics solution was at issue, Ms. Joslin said of the local study. The product in question posted U.S. sales of $12.6 million in the first quarter, compared with overall company sales of $251.7 million.

Earlier AMO Complete MoisturePlus Recall
On November 22, 2006, 2.9 million packets of its Complete MoisturePlus Multi-Purpose contact-lens solution and Active Packs have been recalled by Advanced Medical Optics Inc. after three lots sold in Japan were found to have bacterial contamination. The recall includes 183,000 Complete MoisturePlus units sold in the United States.

Advanced Medical Optics Inc., blamed the the contamination of the Complete MoisturePlus product on a water-borne organism that got into some solution at the company's plant in China. The company has said that the plant has been shut down until the problem is corrected. Advanced Medical said that the lens solution itself is not responsible for the contamination. The Complete MositrePlus recall comes just six months after Bausch & Lomb recalled its ReNU with MoistureLoc multipurpose solution after the product was linked with a Fusarium keratititis, a rare but serious fungal eye infection.

The contamination became apparent after a retailer in Japan complained that some bottles of lens cleaner appeared to be damaged. The company traced the units to the plant in China and found that Ralstonia bacteria had compromised the disinfectant in the solution and were eating away at the oxygen in the bottles.

Multi-purpose lens cleaners such as Complete MoisturePlus accounted for about 17 percent of Advanced Medical's $920.7 million in global sales last year, according to the company's annual report.

Complete MoisturePlus Recall Lawsuit Attorneys
Our lawyers have representad hundreds of people injured by recalled product including Complte MoisturePlus contact lens solution with compassion and understanding. If you or a loved one has used the recalled Complete MoisturePlus Multi-purpose contact lens solution and you suffered an eye injury or eye infection, please fill out the form to the right for a free Complete MoisturePlus lawsuit case evaluation from one of our experienced attorneys.