Dec 24 (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.
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)
