LASIK ads must warn consumers of risks: FDA

By Susan Heavey

WASHINGTON (Reuters) - Doctors, clinics and others promoting corrective eye surgery known as LASIK need to make sure their advertisements tell consumers about possible risks, U.S. regulators said in a letter released on Friday.

The Food and Drug Administration, which has been investigating patient complaints over the procedure, told healthcare providers that commercials and other promotions that do not convey necessary warnings, side-effects and other precautions are deceptive.

"Advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading," wrote Timothy Ulatowski, head of the Office of Compliance for the FDA's Center for Devices and Radiological Health.

The letter comes more than a year after the FDA held a public meeting that drew dozens of unhappy patients who complained of blurriness, double-vision, depression and other problems after undergoing LASIK, or laser-assisted in-situ keratomileusis.

Surgeons and other industry groups said the procedure is safe and effective when done properly and that most patients are satisfied with their vision afterward.

LASIK involves cutting a flap in the eye and then using a laser to reshape the cornea, aiming to improve patients' vision so they can avoid glasses or contact lenses. About 700,000 Americans have undergone the procedure since it was approved in 1998, industry estimates have shown.

The FDA's letter spares LASIK-related companies which could have been hurt by stricter action, including device makers Abbott Laboratories' unit Abbott Medical Optics Inc, Alcon Inc, and Bausch & Lomb as well as clinics such as TLC Vision Corp and LCA Vision Inc.

A weak U.S. economy has already dampened demand for the elective surgery, which can cost several thousand dollars per eye and is not covered by most health insurers.