FDA Announces Plans for LASIK Quality of Life Project

Agency also Announces Warning Letters Issued to LASIK Facilities

SILVER SPRING, Md., Oct. 15 /PRNewswire-USNewswire/ -- The U.S. Food and Drug
Administration today announced the launch of a collaborative study with the
National Eye Institute and the U.S. Department of Defense to examine the
potential impact on quality of life from Laser-Assisted In Situ Keratomileusis
(LASIK), a surgical procedure that uses an excimer laser to permanently change
the shape of the cornea.

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The goal of the LASIK Quality of Life Collaboration Project is to determine
the percentage of patients with significant quality of life problems after
LASIK surgery and identify predictors of these problems.

Funded by the government agencies, the project is composed of three phases.
The objective of Phase 1, which began in July 2009, is to design and implement
a Webbased questionnaire to assess patient-reported outcomes and evaluate
quality of life issues post-LASIK, some of which may relate to the safety of
the lasers used in the LASIK procedure.

Phase 2 will evaluate the quality of life and satisfaction following LASIK as
reported by patients in a select, active duty population treated at the Navy
Refractive Surgery Center.

Phase 3 will be a national, multi-center clinical trial and will study the
impact of the procedure on quality of life following LASIK in the general
population. Patient enrollment in Phases 2 and 3 have yet to begin but plans
are underway. Phase 3 is expected to end in 2012.

The results of the project will help identify factors that can affect quality
of life following LASIK and potentially reduce the risk of adverse effects
that can impact the surgical outcome. If any of these factors related to the
safety or effectiveness of the lasers used in LASIK surgery, the FDA will
evaluate whether any action is necessary. The project is part of the FDA's
ongoing effort to better monitor and improve the safety and effectiveness of
the lasers used in LASIK surgery.

"This study will enhance our understanding of the risks of LASIK and could
lead to a reduction in patients who experience adverse effects from the
procedure," said Dr. Jeffrey Shuren, acting director of the FDA's Center for
Devices and Radiological Health.

The FDA also announced that it issued warning letters to 17 LASIK ambulatory
surgical centers after inspections revealed inadequate adverse event reporting
systems at all the centers. The inspections did not identify problems with the
use of the LASIK devices at these facilities.

Under legislation passed in 1990, user facilities, which include nursing
homes, outpatient clinics and ambulatory surgical centers, must report
device-related deaths to the FDA and to the device manufacturer. They also
must report device-related serious injuries to the manufacturer or to the FDA
if the manufacturer is not known. Requirements include having a written
protocol for adverse event reporting.

The FDA inspected ambulatory surgical facilities that perform LASIK over the
past several months and additional inspections are pending. The FDA regulates
ophthalmic lasers used in LASIK, including monitoring their continued safety
and effectiveness by analyzing reports on their post-market use.

"Many people in the U.S. undergo LASIK procedures," said Shuren. "Ambulatory
surgical centers that perform LASIK must maintain a robust reporting system as
required by law. Reporting adverse events to the FDA is critical to better
understand the safety and effectiveness of ophthalmic lasers used in LASIK
procedures and to enable the FDA to take appropriate actions where the lasers
do not meet safety and effectiveness requirements."

For more information:

The FDA's Web site on LASIK:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/default.htm

FDA Guidance: Medical Device Reporting for User Facilities:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095266.pdf

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 1-888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Media Inquiries: Peper Long, +1-301-796-4671, mary.long@fda.hhs.gov