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Latest on FDA's LASIK Program

On April 25, 2008, the FDA convened a public advisory panel of outside experts to listen to patient experiences with LASIK and consider how to improve information for patients and physicians about LASIK.

In response to the feedback from the public and LASIK experts, we have been working on several improvements in our communications with the public regarding LASIK-related safety issues. Our accomplishments to date include:

• FDA LASIK Web site
• We’ve made it easier for LASIK patients to report problems within two clicks from the FDA LASIK Web site: On the LASIK home page, select the Report a Problem at the bottom of the left column, then select Report a LASIK Problem to MedWatch
• We’ve updated the “Other Resources” section of the Web site to provide a wider range of information about LASIK to patients and physicians.
• We’ve clarified the “Contact Us” section on how to submit a question about LASIK to FDA, and how to submit a comment or concern about LASIK to the public record.

• SightNet
• We’ve updated LASIK-related information in SightNet, a program used by health care professionals at participating facilities to share concerns about potential safety issues with ophthalmic medical devices, and report problems to FDA. The updated information includes:
• an emphasis that halos, glare, night vision problems and dry eye from LASIK should be reported to FDA.

• Patient Information Card
• We’ve worked with the American Academy of Ophthalmology to develop a card that physicians can fill out with the patient’s eye measurements before their LASIK surgery. Patients can keep this card to help their doctor calculate the lens implant power should they need to have future cataract surgery.

These are just a few of the ways FDA is working to ensure that patients and physicians have current, accurate information to help them with their decisions about LASIK and to facilitate their reporting problems. As we continue to monitor the safety and effectiveness of LASIK we will also explore additional ways that we can improve the quality of information available to the public about LASIK and ways to ensure that FDA receives better information about problems with LASIK.

Updated September 18, 2008

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