May 19, 2009
Certified Mail – Return Receipt Requested
The U.S. Food and Drug Administration (FDA) is issuing this letter to firms with cleared pre-market notification submissions for contact lens multipurpose solution products that include "no rub" directions. We would like you to be aware of the following information, including the discussion and recommendation of the Ophthalmic Devices Panel Advisory Committee.
The Center for Devices and Radiological Health (CDRH) has been involved with the Centers for Disease Control and Prevention (CDC) twice in the past two years concerning outbreaks of rare corneal pathogens associated with use of specific "no-rub" contact lens multipurpose solutions. Each outbreak resulted in a Class I recall of a multipurpose "no-rub" solution whose use CDC found to be associated with the infection.
On June 10, 2008, the CDRH Ophthalmic Devices Panel Advisory Committee met to discuss issues concerning post-market experience with various contact lens care products, including the appropriateness of the current "no rub" care regimens and directions for use in product labeling . The panel concluded that there is improvement in lens care when using a "rub-and-rinse" regimen as compared to a "rinse alone" regimen. This is because "rub-and-rinse" regimens help prevent microbial adhesion to the contact lens, help prevent formation of biofilms, and generally reduce the microbial load on the lens and the lens case.
The panel’s opinion is consistent with several professional organizations, including the American Academy of Ophthalmology, the American Optometric Association and the American Academy of Optometry which also recommended that a "rubbing" step be used during routine lens care.
The panel also discussed the effects of water exposure to contact lenses and lens storage cases. The panel supported a labeling warning to avoid use of water or other non-sterile solutions to rinse contact lens storage cases, since non-sterile solutions use can lead to serious eye infection and loss of vision.
We would be interested in your thoughts on the panel’s recommendations. We would like to review any risk analysis results that you may have and discuss any proposed action you may take to address these concerns. We would appreciate your response within 45 days of receipt of this letter. Please direct your comments and information to Ms. Betty W. Collins, Director, Division of Enforcement A, Office of Compliance, HFZ-320, 9200 Corporate Blvd., Rockville, Maryland, 20850.
If you have questions relating to this matter, please feel free to call Ms. Collins, at 301-796-5770 or log onto our Web site at www.fda.gov for general information relating to FDA device requirements.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and