FDA Launches Investigation of LASIK Eye Surgery Problems
The Food and Drug Administration is taking a closer look at LASIK eye surgery and trying to find out just how many people have suffered significant health problems following the popular vision-correction procedures.
The FDA, the National Eye Institute, and the U.S. Department of Defense said today they are launching a collaborative study of LASIK, also known as Laser-Assisted In Situ Keratomileusis, which uses a computer-guided laser to reshape and smooth the surface of the cornea in order to improve vision.
Millions of people worldwide have had LASIK surgery and there have been reports of some patients suffering blindness, decreased vision, lingering eye pain, and other complications following the procedures. The FDA and others said they are conducting an extensive study of LASIK procedures to better determine how many problems are associated with the popular vision-correction surgeries.
“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.
FDA Warns LASIK Centers About Reporting of Problems
Also today, the FDA announced it has sent warning letters to 17 LASIK ambulatory surgical centers after inspections found the facilities were using inadequate adverse event reporting systems to track patient complaints after LASIK surgeries.
Since 1990, federal law has required nursing homes, outpatient clinics, and ambulatory surgical centers to report deaths linked to the use of all medical devices to the FDA and to the device manufacturer. Healthcare providers also must have in place written rules for reporting of adverse events.
“Many people in the U.S. undergo LASIK procedures,” Shuren said. “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.”
The FDA regulates ophthalmic lasers used in LASIK, including monitoring their continued safety and effectiveness by analyzing reports on their post-market use.
Three-Phase LASIK Study Planned
The government-funded study of LASIK procedures will be conducted in three phases, officials said. In the first phase, which began in July, officials will circulate a Web-based questionnaire to collect reports of LASIK-related adverse events and evaluate effects LASIK has had on patients’ lives.
In phase two, officials will evaluate quality of life and satisfaction rates after LASIK surgeries performed on some active-duty military personnel at the Navy Refractive Surgery Center.
Phase three of the government’s LASIK study will consist of a nationwide clinical trial to study the impact of LASIK surgery on quality of life among a larger group of Americans. The study is slated to end in 2012, officials said.
“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,” the FDA said in announcing the LASIK investigation. “If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary.”
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