FDA Statement in Response to 'GMA's' Story on LASIK Eye Surgery

Below is the FDA's response to "Good Morning America's" story about LASIK eye surgery.

CLICK HERE to read "GMA's" story.

What are you doing to look into all the complaints about LASIK?

The FDA is concerned about reports of patient problems post-LASIK. The agency has established and promoted better mechanisms for reporting adverse events, update information on our Web site to better communicate the risks and benefits of this procedure and to better monitor and improve the safety and effectiveness of the lasers used in the LASIK surgery.

In addition, we have taken several steps to try and better understanding the nature of potential problems and how the FDA may help patients, health care providers and manufacturers avoid them.

This year, the FDA issued a letter to LASIK providers outlining issues related to advertising, specifically what may constitute false and misleading advertising regarding LASIK.

The FDA's Office of Compliance inspected a number of LASIK facilities, which revealed inadequate adverse event reporting systems. The agency issued warning letters to errant facilities and will follow up on their remedial actions.

On the regulatory front, the agency has recognized a specific standard, which outlines the testing and clinical studies necessary for the FDA to approve any new lasers used in this surgery.

We have also been hard at work developing our plans for a national study on post-LASIK problems. More details are outlined below.

All of this and more information are updated regularly on the FDA's Web site.

When do you expect to have your studies completed on the "quality of life" issues?
The results from this project will help the FDA 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 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.

The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant health-related quality of life problems after LASIK surgery and identify predictors of these problems. The Project is composed of three phases. In an effort to maximize time efficiency, FDA is working in collaboration with the Department of Defense and the National Eye Institute on planning and execution of all three phases simultaneously. In Phase 1 of the project, we are developing a new Web-based questionnaire to assess patient-reported outcomes post-LASIK. The electronic format of this questionnaire will be used during Phase 2 and Phase 3.

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