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FDA Warning for Misleading LASIK Eye Surgery Ads

December 21, 2012 — In an ongoing campaign against LASIK eye surgery providers who fail to provide adequate risk information, the U.S. Food and Drug Administration (FDA) has sent a Warning Letter to five more clinics. Some of the most serious risks of LASIK include severe dryness, visual problems that can be disabling (halos, glare, starbursts, double vision, etc.), and permanent vision loss. The FDA reminds patients that the surgery is permanent and not all patients will achieve optimal results, and patients may require glasses or contacts after surgery.

The surgery centers who received warning letters include the following:

  • 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

The FDA also sent warning letters to LASIK providers in May 2009 and September 2011. Unfortunately, despite these warnings, the FDA has continued to receive reports from patients who were not fully informed of the risks, limitations, or indications for LASIK eye surgery.

In March 2012, the FDA also sent letters to several medical journals, including the American Society of Cataract and Refractive Surgery and the American Academy of Opthalmology. The FDA asked these journals to provide additional information about disclosing risk information in advertisement and promotional materials.

According to the FDA:

“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, which stands for “Laser Assisted In-Situ Keratomileusis,” is a type of eye surgery used to help reduce a patient’s reliance on glasses or contacts for vision. During the procedure, a physician uses refracted lasers to permanently change the shape of the eye — specifically, the cornea, which is the clear lens that covers the front of the eye.

Do I have a LASIK Eye Surgery Lawsuit?

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