3 Yrs After ReNu with MoistureLoc Outbreak, FDA Reports on Contact Lens Safety EffortsJun 17, 2009 | Parker Waichman LLP
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.