FDA Taking Steps To Improve Contact Lens Safety

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 17 Jun 2009 - 7:00 PDT

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The U.S. Food and Drug Administration is taking steps to improve contact lens safety by reminding consumers of the importance of following proper cleaning and storing procedures. Consumers who do not follow instructions for contact lens care and use increase their risk of serious eye infections that can lead to blindness.

To support proper cleaning and storage, the FDA has developed a new video on contact lens safety, which can be found on the FDA's Web site (http://www.fda.gov), along with an in-depth Consumer Update article. The video and the 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. Other important lens care tips 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.

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 a 2008 meeting of the agency's advisory panel for ophthalmic devices, the FDA is developing manufacturer guidance on potential labeling improvements for these products.

In its 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.

On May 19, 2009, the FDA's 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.

For more information:

The FDA's Information on Contact Lens Safety
FDA Consumer Update on contact lens safety
The FDA's Joint Workshop on Microbiological Testing for Contact Lens Care Products , January 2009
The FDA's Letter to Firms with Marketing Clearance for No-rub Multipurpose Contact Lens Solutions
Commissioner's Guest Viewpoint on Ensuring Safe Use of Contact Lens Solutions

Source
U.S. Food and Drug Administration

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