Renu with MoistureLoc, Other Contact Lens Solution Recalls Result in FDA Safety ReviewJun 6, 2008 | Parker Waichman LLP
Contact lens solutions have been slated for a Food & Drug Administration (FDA) safety review. The FDA decided to embark on the review after some popular brands of contact lens solutions - including Renu with MoistureLoc - were linked to potentially blinding infections.
An FDA advisory pane is scheduled to meet on June 10 to discuss safety issues surrounding contact lens solutions. The panel will recommend to the agency whether the solutions should be subjected to new testing methods, or should bear new safety labeling. The FDA is not bound to follow the recommendations of its advisory panels, but does so in most cases.
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's Complete MoisturePlus solution, prompting the Santa Ana, California-based company to recall the product.
The Renu with MoistureLoc recall, in particular, points to the need for better testing of contact lens solutions. In January, researchers led by Mahmoud A. Ghannoum, Ph.D., director of the Center for Medical Mycology, discovered one important factor behind the inability of Renu with MoistureLoc to resist contamination with the fungus Fusarium. A study done at the center found the strain of Fusarium responsible for the Renu with MoistureLoc 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.
Not all cells can form biofilms, and unfortunately for Renu victims, contact lens solutions are not required to be tested against microbes with this ability. In fact, Renu with MoistureLoc and other contact lens solutions are tested against a rare type of fungus obtained from a patient in Nigeria in 1970s.
When the Renu with MoistureLoc study was released, critics cited it as evidence that manufacturers like Bausch & Lomb are not doing enough to insure the quality of its contact lens solution. “It’s ridiculous that a contact lens solution would only be tested against a microbe that has no real world relevance,” Jerrold Parker, Managing Partner of Parker Waichman LLP, a law firm representing many Renu with MoistureLoc victims, said at the time. “There is no way Bausch & Lomb could guarantee the safety of Renu MoistureLoc on the basis of these inadequate tests.”