U.S. warns LASIK clinics over side effect reporting

By Susan Heavey

WASHINGTON (Reuters) - More than a dozen LASIK eye centers have poor systems in place to report any side effects in patients who have undergone the vision correction surgery, U.S. health regulators said on Thursday.

There were no problems found with the laser devices used in the procedure, but U.S. Food and Drug Administration inspectors found problems with side-effect reporting systems at 17 LASIK vision correction centers.

Warning letters were sent to the clinics, including some TLC Vision Corp and LCA Vision Inc centers.

More inspections are pending, the FDA said. Clinics are required to report side effects to equipment manufacturers and the FDA.

LASIK, short for Laser-Assisted In Situ Keratomileusis, aims to improve vision by cutting a flap in the eye and then using a laser to reshape the cornea.

Patients tend to seek out the surgery to avoid glasses or contact lenses, but side effects can include blurred and double-vision.

The procedures have seen greater FDA attention in recent months. In May, the agency demanded that providers make the risks clear in their advertisements, a year after FDA's outside advisers urged greater action to protect consumers.

Millions of Americans have undergone the voluntary procedure, but demand has weakened in recent years along with the slumping U.S. economy.