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Contact Lens Solutions Need More Testing, FDA Panel Says

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Disturbed by the blinding eye infections caused by tainted ReNu with MoistureLoc and Advanced Medical Optics (AMO) Complete MoisturePlus, a Food & Drug Administration (FDA) advisory panel has called for tougher testing and warnings for contact lens solutions. Critics of contact lens solution makers have long contended that current testing methods are not enough to insure the products’ safety. The FDA is not bound to follow recommendations of advisory panels, but in most cases, it does so.

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.

Earlier this year, 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.

Another recall in 2007 also pointed to a need for better testing of solutions. 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. There is no requirement at this time for solutions to be tested against Acanthamoeba.

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.

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