Monday, October 19, 2009

FDA studies potential LASIK problems

The Los Angeles Times (10/19, Healy) reports that the FDA, the Defense Department, and the National Eye Institute "announced last week that they are launching a three-year effort to gauge how many, and which, patients suffer troubling symptoms after undergoing" Lasik. "In the first phase of the FDA-led effort to measure Lasik's effects, the agency is drafting a Web-based survey of patients who have undergone the procedure." Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said that "the study likely will identify which patients are at higher risk of poor outcomes and 'could lead to a reduction' in those whose eye problems are made worse by the procedure." The FDA also "issued letters reminding 17 walk-in surgical centers performing Lasik surgery of their obligation to report poor outcomes and patients' surgery-related medical complaints."
States' healthcare experiences said to offer lessons for reform.

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