LASIK: Quality of Life Project, Warning Letters to Facilities

LASIK: Quality of Life Project, Warning Letters to Facilities

Printer-friendly PDF (336 KB)
http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM187357.pdf

On this page:
Quality of Life Study
Warning Letters

On Oct. 15, 2009, the U.S. Food and Drug Administration (FDA) made two announcements related to LASIK:

The launch of a collaborative study to examine the potential impact on individuals’ quality of life from LASIK surgery, and
The issuance of warning letters to 17 LASIK ambulatory surgical centers—those that perform surgery and release patients the same day—after inspections revealed inadequate systems for reporting unexpected side effects (adverse events).
LASIK—an acronym for Laser-Assisted In Situ Keratomileusis—is a surgical procedure that uses an excimer laser to permanently change the shape of the cornea, the clear covering of the front of the eye. The procedure is intended to reduce a person’s dependency on glasses or contact lenses.

FDA regulates medical devices in the United States, including lasers used in LASIK. The agency monitors their continued safety and effectiveness by analyzing reports on their use after they are on the market.

Quality of Life Study
FDA has launched a collaborative study with the National Eye Institute (NEI) and the Department of Defense to examine the potential impact on quality of life from LASIK.

Results from the LASIK Quality of Life Collaboration 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.

Funded by FDA, NEI, and the Defense Department, the project consists of three phases:

Phase 1, which began in July 2009, involves design and implementation of a Web-based instrument, such as a questionnaire, to assess outcomes reported by LASIK patients and evaluate quality of life issues after LASIK surgery, 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 at Naval Medical Center San Diego.
Phase 3, expected to end in 2012, will be a national, multi-center clinical trial and will study the impact on quality of life following LASIK in the general population, including subpopulations who may be vulnerable to adverse effects from the procedure.
Plans are under way to prepare for enrolling patients in Phase 2 and to complete the protocol for Phase 3.

The project is part of FDA’s ongoing effort to better monitor and improve the safety and effectiveness of lasers used in LASIK surgery. Its results will help identify steps that can reduce the risk of adverse effects from the surgery that can significantly impact patients’ quality of life.

“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,” says Jeffrey Shuren, M.D., acting director of the FDA’s Center for Devices and Radiological Health.

Warning Letters
On Oct. 9, 2009, FDA 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 outpatient clinics and ambulatory surgical centers, must report device-related deaths to FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to FDA if the manufacturer is not known. Requirements include having written procedures for adverse event reporting.

“Many people in the U.S. undergo LASIK procedures,” says Shuren. “The law requires that ambulatory surgical centers performing LASIK maintain a robust reporting system as required by law. Reporting adverse events to FDA is critical in helping us to better understand the safety and effectiveness of the ophthalmic lasers used in LASIK procedures and it will enable us to take appropriate action where the lasers do not meet safety and effectiveness requirements.”

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: October 20, 2009

abrir aquí para acceder al documento FDA:
LASIK: Quality of Life Project, Warning Letters to Facilities