WASHINGTON DC, October 15, 2009 -- The US Food and Drug
Administration has issued warning letters to 17 Lasik centers citing
poor complication reporting systems. Some clinics for the national chains
LasikPlus and TLC are among those cited.
No problems were found with the lasers used for Lasik , short
for Laser-Assisted In Situ Keratomileusis, however deficiencies
were found in the procedures for reporting complications from the
eye surgery to reduce the need for corrective lenses. Unwanted side
effects can include blurred and double-vision in a minority of cases.
The FDA is inspecting reporting systems at other Lasik facilities.
At an April 2008 public hearing the FDA heard from many patients
who had experienced poor Lasik outcomes. Over 6 million Lasik surgeries
have been performed in the US, however fewer than 140 patients had
reported complications at the time of the hearing.