Yourlawyer.com (Advanced Medical Optics (AMO) Complete MoisturePlus News)

AMO Withheld 9 Complete MoisturePlus Infection Complaints

Mon, 22 Jun 2009 00:00:00 -0700

Advanced Medical Optics (AMO), maker of Complete MoisturePlus contact lens solution, had received reports of eye problems linked to the solution long before it was recalled in 2007. According to the Associated Press, documents obtained in the course of lawsuits against AMO show that the company received 9 such reports in the year prior to the Complete MoisturePlus recall, but failed to properly report them.

As we've previously reported, AMO's Complete MoisturePlus solution was linked to dozens of Acanthamoeba keratitis infections in 2007. Acanthamoeba keratitis is a parasitic eye infection that can cause redness and eye pain, as well as tearing, light sensitivity, blurred vision and a feeling that something is in the eye. A "ring-like" ulceration of corneal tissue may also occur. Unfortunately, in most cases of Acanthamoeba keratitis, permanent vision loss occurs, and corneal transplant surgery often is necessary to recover lost vision.

The documents obtained in the course of Complete MoisturePlus lawsuits resulted from a previously undisclosed inspection by the Food and Drug Administration (FDA), the Associated Press said. The papers reportedly show that between February and November 2006, AMO received 9 reports of Acanthamoeba keratitis infections in Complete MoisturePlus users. But it wasn't until the FDA performed an inspection of AMO's headquarters in June 2007 that it learned of those reports, the Associated Press said. By that time, Complete MoisturePlus had already been recalled, and health officials had confirmed nearly 160 cases of the infection in patients across the U.S.

According to the Associated Press, AMO defended is actions by claiming it was not required to report the complaints because the labeling of Complete MoisturePlus did not claim to protect users from the parasite.

In addition to the unreported complaints, the FDA inspection turned up several other violations at AMO, the Associated Press said. Yet the FDA did not issue AMO a warning letter - the normal step taken when violations are found - or take other action against the company. Rather, the Associated Press, the FDA "discussed" the violations with AMO, and the company outlined a plan for fixing problems. The plant is subject to a follow up inspection, the Associated Press said.

3 Yrs After ReNu with MoistureLoc Outbreak, FDA Reports on Contact Lens Safety Efforts

Wed, 17 Jun 2009 00:00:00 -0700

A little more than three years after defective ReNu with MoistureLoc Contact Lens Solution was linked to scores of serious and potentially blinding eye infections, the Food & Drug Administration (FDA) says it is taking steps to improve contact lens safety. Among other things, the agency has developed a new video on contact lens safety, which can be found on the FDA’s Web site, along with an in-depth Consumer Update article.

Bausch & Lomb pulled ReNu with MoistureLoc from Asian markets in February 2006, and did the same in the U.S. in April of that year, after it was linked to an outbreak of Fusarium Keratitis, a potentially blinding eye infection. The company would ultimately issue a worldwide recall of ReNu with MoistureLoc on May 15, 2006.

A Centers for Disease Control (CDC) report on the outbreak found that those infected with Fusarium Keratitis were 20 time more likely to have used the ReNu with MoistureLoc solution. The CDC report determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities. The CDC ultimately confirmed 180 cases of Fusarium Keratitis in the U.S. According to the Associated Press, at least 60 more Americans needed vision-saving corneal transplants.

Other multipurpose contact lens solutions have also been linked to eye infection outbreaks. For example, we’ve previously reported that in 2007 at least 21 cases of infections involving the water-borne acanthamoeba parasite were linked to Advanced Medical Optics (AMO) Complete MoisturePlus solution, prompting the Santa Ana, California-based company to recall the product. Roughly 170 lawsuits are pending against AMO as a result of that outbreak.

According to a posting on the FDA's website, the agency has taken several steps since the ReNu debacle aimed at improving the safety of contact lenses and solutions. In early 2009, the FDA convened a workshop called “Microbiological Testing of Contact Lens Care Products," in collaboration with several eye care professional groups, to develop consensus on test methods for evaluating contact lens solutions. Based on discussions from this workshop and from June 2008 meeting of the agency’s advisory panel for ophthalmic devices, the FDA said it is developing manufacturer guidance on potential labeling improvements for these products.

At the June 2008 meeting, the advisory panel for ophthalmic devices made specific recommendations for contact lens product labeling and directions for use, including adding a discard date on their products, in addition to the usual expiration date. The discard date is the date the solution should be thrown out after opening.

The FDA also reported that last month, its Center for Devices and Radiological Health issued a letter to manufacturers of contact lens multipurpose solution products that include an option for cleaning without a step for rubbing the lenses. This letter informed these manufacturers of the panel's conclusion that there is improvement in lens care when using a rub-and-rinse regimen as compared to a rinse-alone regimen, which omits the rubbing step. The direction to rub and rinse lenses, based on the advice of an eye care professional, has always been part of the labeling for multipurpose contact lens care products.

The FDA's new contact lens safety video and article stress the importance of emptying the solution out of the contact lens case after each use and using the rub-and-rinse method for added effectiveness, the agency said Other important lens care tips in the video and article include:

Do not top off or reuse lens cleaning solution;
Use a contact lens solution to clean, rinse, and then air dry contact lens cases after each use;
Do not expose contact lenses or lens storage cases to any type of water or other non-sterile solutions.

Tainted ReNu, AMO Contact Lens Solutions Prompt FDA Panel to Call for Better Testing

Wed, 11 Jun 2008 00:00:00 -0700

In the past several years, contact lens solutions, including ReNu with MoistureLoc and Advanced Medical Optics Complete MoisturePlus, have been linked to potentially blinding eye infections. Now, a group of Food & Drug Administration (FDA) advisors has recommended that contact lens solutions be subjected to more stringent testing to insure their safety. The panel also recommended that stronger safety warnings be added to the labels of multi-purpose contact lens solutions so that users can know how to avoid contaminating the products.

Contact lens solutions have been subjected to several recalls because of contamination problems that resulted in some users developing serious eye infections. In 2006, Bausch & Lomb issued a worldwide recall of ReNu with MoistureLoc Contact Lens Solution after it was linked to hundreds of cases of Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. Following an investigation, the Centers for Disease Control determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities.

Last year, at least 21 cases of infections involving the water-borne Acanthamoeba parasite were linked to Advanced Medical Optics (AMO) Complete MoisturePlus solution, prompting the Santa Ana, California-based company to recall the product. That AMO recall followed another issued in November 2006, when 2.9 million packets of AMO Complete MoisturePlus Multi-Purpose contact-lens solution and Active Packs were recalled after lots sold in Japan were found to have bacterial contamination. The recall included 183,000 Complete MoisturePlus units sold in the United States. AMO traced the contaminated units to a 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.

Since the outbreaks and recalls, critics of contact lens solution makers have contended that current testing methods are not enough to insure the products' safety. That argument gained added weight earlier this year when researchers at the Center for Medical Mycology found ReNu with MoistureLoc was unable to resist contamination because the strain of Fusarium responsible for the 2006 outbreak had the ability to form biofilms. Biofilms are clusters of microbes held together by a glue-like matrix. This structure made the Fusarium extremely resistant to contact lens solutions and the body’s own immune system. Unfortunately, contact lens solutions are not required to be tested against microbes with the ability to form biofilms. In fact, RenNu with MoistureLoc and other contact lens solutions are tested against a rare type of fungus obtained from a patient in Nigeria in 1970s, which critics say has no real-world applicability.

In the case of the recalled AMO contact lens solution, there is no requirement at this time for solutions to be tested against Acanthamoeba. Following the 2007 recall, researchers found that AMO Complete MoisturePlus had no ability to kill the parasite.

The FDA panel strongly recommended that the agency revamp its requirements for the way companies test their contact lens solutions for safety before selling them. The panel also recommended a variety of strong new consumer warnings for the solutions, including cautions that reusing lens solution can lead to blindness.

The FDA is not bound to follow recommendations of advisory panels, but in most cases, it does so.

Advanced Medical Optics AMO MoisturePlus Side Effects Lawyers Lawsuit Attorney

Wed, 11 Jun 2008 00:00:00 -0700

Advanced Medical Optics (AMO) Complete MoisturePlus Lawyers

Keywords: Advanced Medical Optics | AMO | MoisturePlus | Side Effects | Lawyers | Lawsuit | Attorney

The lawyers and attorneys at our firm are currently offering free case evaluations to people injured by Advanced Medical Optics (AMO) Complete MoisturePlus contact lens solution. In May 2007, AMO issued a recall of Complete MoisturePlus after it was linked to potentially blinding eye infections. This followed an earlier recall of AMO MoisturePlus and other products in November 2006. Our AMO lawyers have already helped many victims of recalled AMO contact lens solution. If you or a loved one were hurt as a result of contaminated Complete MoisturePlus, we urge you to contact one of the compassionate and experienced AMO lawyers at our firm as soon as possible.

AMO Complete MoisturePlus Tied to Rare Eye Infection

On May 26, 2007, the Food & Drug Administration (FDA) announced that AMO was recalling Complete MoisturePlus after it was tied to several cases of Acanthamoeba keratitis. This disorder is a rare parasitic eye infection that can lead to vision loss. Dozens of people sustained life-altering injuries as a result of tainted Complete MoisturePlus, and our AMO lawyers intend to hold this manufacturer accountable for its negligence.

Acanthamoeba keratitis is an often severe, painful infection of the cornea that commonly causes corneal scarring and sometimes blindness. Symptoms of the infection include eye pain or redness, blurred vision, sensitivity to light, the feeling of something in the eye, or excessive tearing. Acanthamoeba keratitis is difficult to treat, and does not respond well to medications. Acanthamoeba keratitis can require patients to undergo corneal transplant surgery, and sometimes multiple surgeries are necessary. Even then, many patients never fully recover their vision.

Although Acanthamoeba keratitis is rare, in the three years prior to the AMO recall, various eye-care centers around the U.S. had been reporting increased cases of the infection. In 2003, researchers at the University of Chicago began tracing 67 cases of Acanthamoeba keratitis, and discovered a significant link between the infections and the AMO solution. This research caught the attention of the Centers for Disease Control (CDC), which began its own investigation.

It did not take long for the CDC to link the AMO contact lens solution to the infections. As of May 24, 2007, in a probe that included 35 states and Puerto Rico, the CDC identified 138 "culture-confirmed" cases and interviewed 46 patients. The CDC found that 36 of those people wore soft contact lenses, 21 reported using AMO Complete MoisturePlus contact lens solution a month before symptoms, and 14 used it exclusively. Ultimately, the CDC found that people who used AMO contact lens solution had a seven-fold increased risk of developing Acanthamoeba keratitis compared with those who used other contact lens solutions.

The CDC discovery prompted AMO to recall 28 million bottles of Complete MoisturePlus on May 26, 2007. Consumers were told to stop using the AMO Complete MoisturePlus contact lens solution, and to discard any unused product. AMO solution users were also told to replace both their contact lenses and their lens storage container. In July, the Food & Drug Administration (FDA) reclassified the AMO recall to a Class 1 recall because there was a reasonable probability that Complete MoisturePlus could cause serious injury.

Unfortunately, not all AMO Complete MoisturePlus users were made aware of the recall. Our AMO lawyers have learned of several instances where contact lens users suffered injury from Complete MoisturePlus months after the recall was announced. It is our firm's contention that AMO did not do enough to publicize the Complete MoisturePlus recall.

Other Contact Lens Solution Recalls

The AMO Complete MoisturePlus recall was the company's second such recall in a six month period. On November 22, 2006, 2.9 million packets of AMO Complete MoisturePlus Multi-Purpose contact-lens solution and Active Packs were recalled after lots sold in Japan were found to have bacterial contamination. The recall included 183,000 Complete MoisturePlus units sold in the United States. The contamination became apparent after a retailer in Japan complained that some bottles of lens cleaner appeared to be damaged.

AMO traced the contaminated units to a 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. Our AMO lawyers see these two recalls - announced within such a short time of each other - as proof that AMO employed shoddy manufacturing practices. As a result, some of their customers will have to live with impaired vision for the rest of their lives. The AMO lawyers at our firm are committed to making sure these victims receive the justice they deserve.

The May 2007 AMO Complete MoisturePlus recall came just over a year after Bausch & Lomb recalled its Renu with MoistureLoc contact lens solution. Renu with MoistureLoc had been implicated in hundreds of cases of Fusarium keratitis, another rare eye infection that has the potential to cause blindness. Our AMO lawyers have represented several victims of Renu with MoistureLoc, and are also offering free consultations to anyone injured by this product.

The AMO and Renu with MoistureLoc recalls indicate that the makers of contact lens solutions are not doing enough to insure the safety of their products. In the wake of these recalls, the FDA announced it would be conducting a safety review of contact lens solutions. An FDA advisory panel is slated to take up the matter in June 2008. The panel could ultimately recommend that contact lens solutions be subjected to more stringent testing requirements, and that these products bear stronger safety warnings on their labels.

Legal Help for Victims of AMO Complete MoisturePlus

Our firm has represented many victims of defective contact lens solutions with dignity and compassion. If you or someone you know has been injured as a result of contaminated AMO Complete MoisturePlus contact lens solution, you have valuable legal rights. Please fill out our online form, or call 1-800 LAW INFO (1-800-529-4636) to discuss your case with an experienced AMO lawyer.