A woman who underwent seven corneal transplants after contracting a devastating eye infection encouraged a panel of FDA consultants Tuesday to recommend to the Agency that it immediately strengthen testing and labeling requirements for contact lens disinfectant solutions.
Sheila Kinsey addressed a packed meeting of the FDA Ophthalmic Advisory Committee, a group of eye doctors and scientists appointed to make recommendations to FDA about the safety of multipurpose contact lens solutions. The FDA meeting came a year after Advanced Medical Optics, Inc. recalled Complete® MoisturePlus™ lens solution from the market after the Centers for Disease Control linked the product to corneal infections caused by a parasite known as Acanthamoeba.
Kinsey said she first developed an Acanthamoeba infection in 2001 after using a multipurpose solution to disinfect her soft contact lenses. The single mother of two lost vision in the infected eye and was forced to relocate without her family from Los Angeles to Iowa City, Iowa where Acanthamoeba specialists have been trying to prevent her from losing the affected eye. Six of the seven new corneas transplanted into her eye were either rejected or became reinfected by the parasite.
Kinsey said she and many other people became infected with the bug because the disinfectant in her contact lens solution was ineffective against Acanthamoeba. In May of 2007, a CDC study identified an outbreak of Acanthamoeba infections in contact lens wearers who used multipurpose solutions. The majority of the victims reported using Complete® MoisturePlus™.
At the meeting on Tuesday, FDA and CDC researchers presented the results of investigations showing that many lens solutions have little or no affect against Acanthamoeba, and asked the advisory panel to make recommendations on making solutions safer for consumers. The committee overwhelmingly recommended new pre-market testing guidelines as well as the strengthening of product labels and increased consumer education.
Thomas M. Moore, of the Newport Beach, California law firm Moore Labriola LLP, also addressed the panel. Moore, who along with Michael Schmidt of The Schmidt Firm, LLP in Dallas, Texas and Schmidt & Clark, LLP in Washington, D.C. represents dozens of Acanthamoeba victims in litigation against Advanced Medical, the maker of Complete® MoisturePlus™, encouraged FDA to require solutions to be effective against Acanthamoeba and to make manufacturers clearly warn about the risk of infection.
“There is an opportunity for FDA to change the direction of the contact lens care industry, and by so doing, make contact lens wear substantially safer for millions of Americans,” said Moore.