ROCKVILLE, Maryland, May 22, 2009, /FDA/ -- The US Food
and Drug Administration (FDA) has published a "Dear Doctor"
letter admonishing Lasik surgeons who do not adequate inform
potential patients of the limitations and risks associated with
Lasik and other laser vision correction surgery techniques in
On April 25, 2008, FDA’s Ophthalmic Devices Panel held a
public meeting to discuss issues concerning post-market
experiences with LASIK procedures. A representative of the
Council for Refractive Surgery Quality Assurance presented the
preliminary results of the USAEyes Competence Opinion
Relative to Expectation (CORE) Lasik patient survey at this
meeting, showing that over 98% of laser vision correction
surgery patients would have surgery again, knowing what they
know now. See
Lasik Results for details.
Both at the meeting and
through submissions to a subsequently established public docket,
the FDA has received information, comments, and complaints from
interested persons regarding the promotion and advertising of
LASIK procedures and the FDA-approved lasers used in LASIK
procedures. The FDA has received complaints that eye care
professionals’ advertisements for LASIK procedures and
FDA-approved lasers used for the LASIK procedures failed to
inform consumers of the indications, limitations, and risks
associated with LASIK procedures and the approved lasers used
for the LASIK procedures.
In response, the FDA has asked all doctors to help eliminate
"deceptive or misleading health-related advertising
claims" as an important part of protecting the public health.
FDA Lasik Advertising Letter