FDA issues Warning for LASIK Surgeons

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The US FDA is again attacking on eye care professionals who are making false safety claims and make false promise about the very popular LASIK eye surgery. The agency issued a letter this week to the eye care professionals. This letter followed an earlier warning that was issued in May 2009. The FDA has now given eye doctors 90 days to update any promotional or advertising materials that they have created which make false claims. FDA spokesperson Erica Jefferson said that the agency will start taking regulatory action after this. She also said “It’s about the false claims and not adequately providing consumers with information about the risks associated with the procedure.”

LASIK is a laser procedure which shapes the cornea. There are a few risks involved with LASIK surgery. The risks are both severe and small. A few common risks associated with the surgery are loss of vision, dry eyes, glare, halo or double vision, under or over correction of eye sight. LASIK surgery is not for everyone. Till date the surgery can be used to help repair vision in people who suffer from nearsightedness, farsightedness or astigmatism. These conditions are known as refractive errors. The FDA did not point out any examples of misleading advertisement and false claims by eye care professionals. A 2008 guideline which was issued by the US Federal Trade Commission included the following points:
LASIK surgeons

  • There must be ‘reasonable basis’ for its claims before the advertisement is released. Statements from customers who are satisfied will not prove to be sufficient for supporting a healthy or safety claims that require some sort of objective evaluation.
  • Some important omissions should be made in advertisements. There are some advertisements which tell only half the truth and not the complete truth.
  • Any claims of safety made should be authentic. If there are any risks involved with the process then should be specified clearly.

Dr. Eric D. Donnenfeld on behalf of American Society of Cataract and Refractive Surgery said that the group is supporting the efforts of FDA. Dr. Eric said that LASIK surgery is completely safe when it is performed by the right doctor and on the right patient. Dr. Eric is an ophthalmologist and his offices are spread across Long Island, New York. He said, “A lot of patients make a decision based on an ad in a magazine or an audio clip on radio, there are a lot of very good doctors who advertise, but it doesn’t mean a doctor is good because he advertises or offers group discounts.”


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