FDA: Doctors Must Tell People About Lasik Eye Surgery Risks
23 5월 2009 - 5:34AM
Dow Jones News
Doctors need to give patients detailed information about the
risks associated with Lasik eye surgery, the U.S. Food and Drug
Administration said in a letter Friday.
The FDA sent a letter to doctors requesting that they tell
patients about risks associated with Lasik eye surgery after
receiving numerous complaints from consumers who experienced double
and fuzzy vision and painful dry eyes after getting the
procedure.
Laser-assisted in situ keratomileusis, or Lasik, is the most
common type of vision-correction surgery. Most people who have the
surgery rave about its success, but some have experienced double
vision and other side effects.
The FDA has been looking into the side effects of Lasik eye
surgery for at least a year. The agency held a public meeting in
April 2008 where consumers expressed concerns about risks
associated with the surgery.
The FDA said it believes "eliminating deceptive or misleading"
health ads is an important part of protecting the public's
health.
More than a dozen companies make laser equipment used during the
procedure. Abbott Laboratories (ABT), through its recent
acquisition of Advanced Medical Optics, is a major manufacturer of
the equipment. Other makers include Bausch & Lomb Inc. and
Alcon Inc. (ACL).
The FDA's letter addresses an industry already struggling as a
result of the recession. Laser procedures are expensive, aren't
covered by insurers, and can easily be deferred as customers choose
to stick with glasses or contact lenses. This slowdown in
procedures has caused turmoil for the publicly traded Lasik
providers, TLC Vision Corp. (TLCV) and LCA-Vision Inc. (LCAV).
-By Jared A. Favole, Dow Jones Newswires; 202-862-9207;
jared.favole@dowjones.com
(Jon Kamp contributed to this report.)