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LASIK eye surgery a little too safe according to some U.S. advertising

December 24, 2012 12:22 pm by | 3 Comments

(Reuters) - U.S. health regulators warned five eyecare providers to stop misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK.

The U.S. Food and Drug Administration found that the advertisements and promotional materials did not offer consumers adequate information about risks and possible side effects.

Warning letters were sent to certain eyecare centers in Indiana, California, Florida, Texas and Georgia.

"Providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection," said Steve Silverman, compliance director at FDA's Center for Devices and Radiological Health in a statement posted on the agency's website.

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Surgery with refractive lasers is intended to reduce the need for glasses or contact lenses. It involves the removal of corneal tissue by a special laser and permanently reshapes the cornea and changes its focusing power.

The most common risks of LASIK surgery include dry eyes, the possible continued need for glasses, visual disturbances such as halos, starbursts or double vision, and even loss of vision.

The FDA said it issued letters in 2009 and 2011 to eyecare professionals across the country explaining the agency's concerns about improper advertising and promotion of FDA-approved lasers.

It also issued letters in March 2012 to the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology, providing additional information about disclosing risk in eyecare professionals' advertisements and promotional materials.

"The FDA reminds consumers that eye surgery such as lasik is irreversible, that not all patients will achieve optimal results, and that some patients may need additional procedures," the FDA said.

(Reporting by Toni Clarke in Boston; editing by Matthew Lewis)

Copyright 2014 MedCity News. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
3 comments
Tom Buczak
Tom Buczak

  Is there an age limit for laser eye surgery?  I am 43 years old, I don't want to wear bi-focals.

berusak
berusak

It is advisable to get assessment done by an independent practitioner, who will not push you into the surgery despite risks. There are also alternatives to LASIK, such as Ortho K contact lenses, which are worn overnight. One should do proper research before deciding on going ahead with the surgery.

Professor Dan Reinstein
Professor Dan Reinstein

The FDA is responsible for keeping the USA 10 years behind the rest of the world in LASIK technology. If the FDA had more efficient and sophisticated approval processes, most of the complications it is referring to would not persist. LASIK complications are almost all correctable with modern technology available worldwide (ex USA) for over 10 years: particularly topography guided custom ablation (available since 1998 and still not approved in the USA). It is the FDA that needs reforming, In order to enable US patients and surgeons to have access to the best technology.

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