FDA Update on LASIK


Question: What has the FDA accomplished in the past year to protect the public from being harmed by LASIK? Answer: Not much.

March 27, 2009 (Gaithersburg, Maryland). Good morning. I’m Kwame Ulmer, Chief of the Diagnostic and Surgical Devices Branch, and this morning I’ll be giving an update on activities in our branch. On April 25, 2008, 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 public and LASIK experts, we’ve been working on several improvements in our communications with the public regarding LASIK-related safety issues.

Our accomplishments to date include FDA LASIK website. We’ve made it easier for LASIK patients to report problems within two clicks from the FDA LASIK website. On the FDA LASIK home page, select report a problem at the bottom left column, and then select report a LASIK problem to MedWatch. We’ve updated the other resources section of the website 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 related information in SightNet, a program used by healthcare 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 LASIK surgery. Patients can keep this card to help the doctor calculate the lens implant power should they need to have future cataract surgery.

FDA recognition of ANSI laser systems for corneal reshaping. In March of 2009, FDA officially recognized the new LASIK standard from the American National Standards Institute, ANSI, entitled Laser Systems for Corneal Reshaping. FDA, as a member of ANSI, works closely with this and other national and international standards organizations. This group meets to develop and come to a consensus on appropriate national and international standards for device testing and performance.

LASIK docket. We’ve opened a public docket for LASIK so that any interested person can post questions, comments, or concerns regarding LASIK. This docket is web-based, and all comments submitted are able to be viewed by the public. All comments on the document are examined in excess by FDA staff on a regular basis. The LASIK docket can be found at www.regulations.gov and can be accessed with the keyword, LASIK, or typing in the LASIK docket number FDA-2008-N-0488.

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’ll 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. Thank you.


Source: Transcript of the 3/27/2009 FDA Ophthalmic Devices Panel. Available at: http://www.fda.gov/ohrms/dockets/ac/09/transcripts/2009-4423t1-001.pdf. Accessed April 30, 2009.