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U.S. warns LASIK clinics over side effect reporting
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.
LCA Vision Chief Financial Officer Michael Celebrezze said the agency inspected 14 of its LasikPlus clinics over the summer. A list provided by the FDA showed letters had been sent to eight locations.
"They did not think our policy was as strong as they would like it to be... we've since revised our policy," he said.
Representatives for TLC Vision did not return a call seeking comment. Four TLC clinics were cited on the FDA's list.
The FDA said affected TLC clinics are in McLean, Virginia; Sewickley, Pennsylvania; and Edgewater and Rockville, Maryland, according to a list provided by the FDA.
LCA Vision centers listed by the FDA were in Chicago, Illinois; Indianapolis, Indiana; Louisville, Kentucky; Raleigh, North Carolina; Lakewood, Colorado; Edina and Maple Grove, Minnesota; and Rockville.
The FDA also said on Thursday it was launching its previously announced joint study with the National Eye Institute and the U.S. Department of Defense to look at what impact the surgery has on patients' quality of life.
Shares of TLC Vision closed down 3.4 percent while LCA Vision's stock closed down 1.7 percent, both on the Nasdaq.
The agency announced the warnings on the agency's website here
Companies that make LASIK-related equipment include Abbott Laboratories' unit Abbott Medical Optics Inc, Alcon Inc, and Bausch & Lomb.
(Reporting by Susan Heavey; editing by Carol Bishopric and Tim Dobbyn)
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