FDA Warning for Misleading LASIK Eye Surgery Ads

December 21, 2012 — The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to five eye care surgery centers for failing to provide adequate risk information in advertisements for LASIK eye surgery. Serious risks of the procedure include severe dry eye syndrome, debilitating visual symptoms (halos, glare, starbursts, double vision, etc.), the need for glasses of contacts, and the loss of vision.

The FDA sent warning letters to the following eye surgery providers:

• 20/20 Institute Indianapolis LASIK, of Indianapolis, Indiana
• Scott Hyver Visioncare Inc., of Daly City, California
• Rand Eye Institute, of Deerfield Beach, Florida
• Eye Center of Texas, of Bellaire, Texas
• Woolfson Eye Institute, of Atlanta, Georgia

This warning letter follows other warnings to other LASIK providers in May 2009 and September 2011. The FDA has continued to receive reports of consumers who say they were misled about the risks, limitations, and conditions LASIK is approved to treat. The FDA also sent letters to several medical journals to request that they provide more information about the importance of disclosing risk information in advertisements.

The FDA warned:

“Any person, including an eye care professional, who misbrands a restricted device through false or misleading advertising, or by causing the device’s labeling to be false or misleading, violates the FD&C Act and is subject to enforcement action.”

LASIK (Laser Assisted In-Situ Keratomileusis) is a surgical procedure intended to reduce a person’s dependence on glasses or contacts to correct vision problems. The procedure uses refracted lasers to permanently change the shape of the cornea, which is the clear covering in the front of the eye.

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