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:
- LASIK Video
- FDA Letter to Eye Care Professionals
- FDA Announces Plans for LASIK Quality of Life Project
- Questions and Answers on the Medical Device Reporting (MDR) Regulation
- LASIK Docket
- FDA Recognition of ANSI Laser Systems for Corneal Reshaping
- Patient Information Card
On December 6, 2011, FDA posted a video on FDA's YouTube channel and FDA's LASIK web site to help explain the risks of LASIK and other important information to potential patients. The video includes images of what certain visual symptoms may look like to patients experiencing them.
In May 2009, we issued a letter to eye care professionals providing them with important information about the promotion and advertising of FDA-approved lasers used during LASIK. Since then, we have received additional complaints about eye care professionals' advertising and promotion of refractive procedures, including LASIK, and FDA-approved lasers used for those procedures. In September 2011, we issued a second letter to remind eye care professionals of their legal responsibility to provide balanced information about medical products. Violators are subject to regulatory and enforcement action. FDA has also issued letters to both the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology providing additional information about disclosing risk information in eye care professionals' advertisements and promotional materials concerning FDA-approved lasers intended for LASIK.
FDA Announces Plans for LASIK Quality of Life Project
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.
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. To view "close-out letters" issued once FDA has verified that corrective actions have been undertaken by ambulatory surgical centers in response to warning letters, visit: LASIK Ambulatory Surgical Centers Closeout Letters
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.
We opened a public docket for LASIK on Sept. 12, 2008 (through Nov. 15, 2010) so that any interested person could pose comments, or concerns regarding LASIK. This docket is web based and all comments submitted are able to be viewed by the public. 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.
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.
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.