Source | DOW JONES NEWSWIRES

By Jon Kamp

U.S. health authorities are concerned that contact-lens wearers are still using an Advanced Medical Optics Inc. (EYE) lens solution pulled from the market two months ago due to infection links, and that the company hasn’t done enough to raise public awareness.

At least four cases of the serious eye-infection Acanthamoeba keratitis have been connected to use of Advanced Medical’s Complete MoisturePlus solution since the late May recall, said Michael Beach, an epidemiologist with the U.S. Centers for Disease Control and Prevention. The CDC has found that many people are unaware of the recall.

The Food and Drug Administration, meantime, recently found that solution bottles are still on some retail shelves, said Tim Ulatowski, director of compliance in the FDA’s medical devices branch. The CDC believes there may also be millions of bottles still in the homes of contact-lens wearers.

Tough-to-treat Acanthamoeba infections can potentially bind people.

“We really want people to hear about this and check their medicine cabinets,” Beach said in an interview with Dow Jones Newswires Tuesday. “To me this is a real tragedy when people are still using the product after the recall.”

The recall has also led to product liability lawsuits against Advanced Medical. In a release Tuesday, law firm Schmidt & Clark LLP said four additional suits have been filed against the company in Orange County Superior Court in California, all brought by individuals alleging they contracted Acanthamoeba infections while using Complete MoisturePlus. The suits were filed by law firm Moore Labriola LLP.

Read The Full Article: http://online.wsj.com/article/BT-CO-20070731-715781.html?mod=djempersonal

[UPDATE 08/01/07] Recall of Complete MoisturePlus Multi-purpose Contact Lens Solution manufactured by Advanced Medical Optics, Inc. classified by FDA as Class I

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

On August 1, 2007 the U.S. Food & Drug Administration announced that many consumers may not be aware of the May 2007 recall of Complete MoisturePlus Multipurpose Contact Lens Solution manufactured by Advanced Medical Optics (AMO) and continue to use the recalled product. Several cases of Acanthamoeba Keratitis have been reported to CDC that involve the use of AMO Complete MoisturePLUS after the recall was announced. Individuals who wear soft contact lenses should stop using the Advanced Medical Optics Complete MoisturePLUS product immediately, discard all remaining solution including partially used or unopened bottles. See the FDA Preliminary Public Health Notification dated May 31, 2007, for recommendations for contact lens wearers.

Learn More About Your Legal Rights: http://www.schmidtandclark.com/Complete-MoisturePlus/

Source | CDC

CDC continues to receive reports from ophthalmologists that cases of Acanthamoeba keratitis, a potentially blinding infection, are occurring in the United States.

Multiple cases of infection caused by Acanthamoeba have occurred since May 26, 2007, the day the FDA announced the outbreak and the manufacturer issued a recall of the implicated multipurpose contact lens solution. The contact lens user in at least four of these cases continued to use AMO Complete® MoisturePlus™ multi-purpose contact lens solution and subsequently developed symptoms after the recall.

CDC has also learned during the interview stage of its investigation of the outbreak that many contact lens users do not know that AMO Complete® MoisturePlus™ multi-purpose contact lens solution has been recalled from the market because of its association with Acanthamoeba keratitis.

Healthy contact lens users from across the U.S. were interviewed by CDC as part of the ongoing investigation. They were asked if they had heard of a recalled contact lens solution and, if so, could they identify the name of that solution. Among the 151 people interviewed:

• 52.3% (79/151) were not aware of the recall
• Among those who were aware of the recall, only 26.8% (19/72) could correctly name the recalled product
• Of 15 people who reported using AMO Complete® MoisturePlus™ multi-purpose contact lens solution in April 2007, 80% (12/15) were still unaware of the recall and were still using the product

While FDA moved swiftly and worked with the manufacturer to enact this recall, millions of bottles of the solution, purchased prior to the recall, might still be in the homes of contact lens wearers. We are concerned that this lack of awareness among the general public — as well as eye care providers — is leading to continued use of the product by those who had purchased it prior to the recall. (It is often sold in bulk packaging at warehouse stores and bottles have a long expiration date).

Help is being sought to get the word out:

1. Check your medicine cabinet for AMO Complete® MoisturePlus™ multipurpose contact lens solution.
2. Stop using the product immediately and contact the company at 1-888-899-9183 or on the AMO Web site for instructions on what to do with unused solution;
3. Discard all soft contact lenses used with AMO Complete® MoisturePlus™;
4. Discard all contact lens storage cases used with AMO Complete® MoisturePlus™;
5. Consult your eye care provider about choosing an alternative contact lens solution;
6. Visit your eye care provider if you experience any signs of eye infection, including eye pain or redness, blurred vision, sensitivity to light, sensation of something in the eye, or excessive tearing and;
7. Visit CDC’s Acanthamoeba Web site for further instructions on contact lens use and other information.

Santa Ana, CA (PRWEB) July 30, 2007 — Four more products liability lawsuits were filed yesterday against the manufacturer of Complete® MoisturePlus™ contact lens solution in Orange County Superior Court in Santa Ana, California (Case #07CC01330, #07CC01331, #07CC01332, #07CC01333). The product was voluntarily recalled on May 25 at the request of the Food & Drug Administration in the wake of data collected and reviewed by the Centers for Disease Control linking the solution to a serious corneal infection known as Acanthamoeba keratitis. The new cases add to a growing number of injury and class action claims arising out of the recall.

Read Full Text: Schmidt & Clark Announces Multiple Lawsuits Filed Over Recalled Contact Lens Solution

Litigation against Advanced Medical Optics Continues to Expand as Company Moves to Re-Enter the Multipurpose Solution Business

SANTA ANA, Calif.–(BUSINESS WIRE)–Four more products liability lawsuits were filed yesterday against the manufacturer of Complete® MoisturePlus™ contact lens solution in Orange County Superior Court in Santa Ana, California (Case #07CC01330, #07CC01331, #07CC01332, #07CC01333). The product was voluntarily recalled on May 25 at the request of the Food & Drug Administration in the wake of data collected and reviewed by the Centers for Disease Control linking the solution to a serious corneal infection known as Acanthamoeba keratitis. The new cases add to a growing number of injury and class action claims arising out of the recall.

The lawsuits, naming vision products manufacturer Advanced Medical Optics, Inc., and its former parent company, Allergan, were brought by Dolores O. Morse, PhD (#07CC01332), and Kelly Segerstrom (#07CC01333), both Southern California residents, as well as Jacqueline Grossman (#07CC01331) and Krista Nelson (#07CC01330), who are residents of Washington. All of the plaintiffs allege that they contracted Acanthamoeba infections while they were using Complete® MoisturePlus™ to disinfect their contact lenses. The cases were filed by Newport Beach-based Moore Labriola LLP, which also filed the first post-recall lawsuit against AMO on June 4 (#07 CC 01296). The plaintiffs are also represented by Michael Schmidt of The Schmidt Firm and Schmidt & Clark, both based in Dallas.

Acanthamoeba infections can be chronic, resistant to treatment, and often require surgical interventions such as corneal transplantation. They not infrequently lead to blindness. Morse and Grossman both underwent surgical procedures as the result of infection-related damage and have lost the use of the affected eyes. Segerstrom is hopeful she has gotten through the worst of her infection thanks to intensive treatments, but still experiences vision problems. Nelson, a 16 year-old, continues to fight her infection, which was diagnosed last November. She is believed to be the first minor to file suit against AMO since the recall.

“We expect the litigation to grow significantly over the next several months,” said attorney Michael Schmidt, who added that his firm represents numerous Acanthamoeba victims from across the Country. Schmidt noted that many of the victims are minors. “AMO specifically targeted teenage contact lens wearers, like Krista, in their marketing campaigns,” said Schmidt, who noted that young people appear to be particularly susceptible to the risks of ineffective lens disinfectants.

According to the lawsuits, studies published well before the product was recalled showed the disinfectant in Complete® MoisturePlus™ was vastly inferior to hydrogen peroxide as well as other multipurpose contact lens solutions on the market in eradicating Acanthamoeba. The plaintiffs allege that AMO was aware of the ineffectiveness of their product but concealed that information from consumers.

The new lawsuits come a week after AMO announced plans to re-enter the multipurpose lens solution business. According to recent press reports, the company says it will start distributing an “older” formulation of the recalled product as early as August. The product will reportedly feature revised labeling designed to improve safety, and will instruct users to manually rub their lenses during the cleaning process. AMO had previously represented to consumers that they could effectively disinfect lenses without a rub step, a practice considered unsafe by many optometrists and ophthalmologists.

Attorney Thomas Moore says his clients are concerned that consumers may be misled by the launch of the old AMO formulation and may incorrectly presume the solution is adequately effective against Acanthamoeba. “The label changes are all well and good, but AMO continues to ignore the root problem, which is the ineffectiveness of their disinfectant ingredient under real-world conditions,” says Moore. The solution will reportedly use the preservative polyhexamethylene biguanide, which is the same disinfectant used in the recalled product. “That ingredient in concentrations routinely used by AMO and Allergan has been shown to be ineffective against Acanthamoeba in many published studies,” says Moore, who added that if AMO wants to take a leadership position in the contact lens solution industry, “they should develop a disinfectant that works, and stop blaming consumers for infections which could be prevented with effective products.”

Source | CORNEA - The Journal of Cornea and External Disease

Cornea. 26(6):701-706, July 2007.
Thebpatiphat, Nuthida MD; Hammersmith, Kristin M MD; Rocha, Fabiano N MD; Rapuano, Christopher J MD; Ayres, Brandon D MD; Laibson, Peter R MD; Eagle, Ralph C Jr MD; Cohen, Elisabeth J MD