http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm061421.htmOn 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
o 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
o We’ve updated the “Other Resources” section of the Web site to provide a wider range of information about LASIK to patients and physicians.
o 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
o 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
o 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.
* FDA Recognition of ANSI Laser Systems for Corneal Reshaping
o In March 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 groups. This group meets to develop and come to a consensus on appropriate national and international standards for device testing and performance.
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LASIK Docket
o We have opened a public docket for LASIK so that any interested person can pose 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 docket are examined and assessed by FDA staff on a regular basis. You can submit comments about your LASIK experience to the public record (docket) at “Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket”. Select the icon next to "Add Comments." Please do not include personal identification information, since this is a docket open for public view. Comments can be viewed at www.regulations.gov with a keyword, e.g., LASIK, or by typing in the LASIK docket number, FDA-2008-N-0488.
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FDA Letter to Eye Care Professionals
o We have issued a letter to eye care professionals providing them with important information about the promotion and advertising of FDA-approved lasers used during LASIK. This letter was sent to the American Academy of Ophthalmology, American Society of Cataract and Refractive Surgery, American Optometric Association, and the Optometric Council on Refractive Technology to help FDA disseminate this important information to their members.
* FDA Announces Plans for LASIK Quality of Life Project
o On Oct. 15, 2009, we issued a press release announcing the launch of a collaborative study with the National Eye Institute and the Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an excimer laser to permanently change the shape of the cornea. The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.
o We also announced that we issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities. To view these letters, visit Inspections, Compliance, Enforcement, and Criminal Investigations: Warning Letters.
* Questions and Answers on the Medical Device Reporting (MDR) Regulation
o We developed some questions and answers on the Medical Device Reporting (MDR) Regulation. This regulation specifies the reporting obligations of medical device manufacturers, importers, distributors, and user facilities. FDA has defined a device user facility as a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility.
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.