The FDA continues to ensure patients and physicians have access to current and accurate information on (Laser-Assisted In Situ Keratomileusis) LASIK to help them make better informed decisions about whether the procedure is right for them, and to help them report any adverse events associated with LASIK to the FDA.
On April 25, 2008, the FDA convened a public advisory panel of national experts who listened to patient experiences and perspectives with LASIK. The advisory panel also considered how to improve LASIK-related information for patients and physicians.
In response to feedback from the public and LASIK experts, the FDA is providing resources related to LASIK.
- Qualification of Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire
- LASIK Video
- FDA Letter to Eye Care Professionals
- LASIK Quality of Life Collaboration 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
Qualification of Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire
The outcome of the LASIK Quality of Life Collaboration Project is the Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) questionnaire.
The PROWL-SS scales are a set of items developed in response to patient concerns related to LASIK procedure outcomes. Included in the PROWL-SS are the Visual Symptoms scales and Satisfaction with Vision item.
- The Visual Symptoms scales include items assessing the existence, bothersomeness, and impact on usual activities in the last seven days of four key visual symptoms: double images, glare, halos, and starburst. These items are administered using a written definition of the symptom and photographic images to illustrate various levels of symptom severity to minimize confusion related to visual symptom terminology.
- The Satisfaction with Vision item is a single response item assessing patient satisfaction with their current vision.
For information about the qualification of the PROWL-SS as an FDA Medical Device Development Tool (MDDT), see the Summary of Evidence and Basis of Qualification (SEBQ) Decision for the PROWL-SS (PDF-##KB). For details on the MDDT program, see Medical Device Development Tools (MDDT).
On December 6, 2011, the FDA posted a video on FDA's YouTube channel and FDA's LASIK page explaining the risks of LASIK and other important information related to the procedure. The video includes images of what certain visual symptoms may look like to patients experiencing them.
In May 2009, the FDA 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, the FDA has received additional complaints about eye care professionals failing to inform consumers of the indications, limitations, and risks associated with LASIK procedures.
In September 2011, the FDA 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. The FDA has also issued letters to 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.
On October 15, 2009, the FDA 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 was to determine the percentage of patients with significant vision-related quality of life problems after LASIK surgery and identify predictors of these problems.
The FDA also announced the issuance of 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 devices used to perform LASIK procedures at these facilities. The FDA issued close-out letters once the FDA has verified that corrective actions were taken by the LASIK ambulatory surgical centers.
The FDA developed 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. The FDA has defined a device user facility as a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility.
The FDA opened a public docket from September 12, 2008 through November 15, 2010, for the public to provide comments or concerns about LASIK. This docket is web-based and all comments that were submitted can be viewed on FDA-2008-N-0488, at www.regulations.gov.
In March 2009, the FDA officially recognized the new LASIK standard from The American National Standards Institute (ANSI), entitled “Laser Systems for Corneal Reshaping.” The 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. The current recognized version of this standard, ANSI Z80.11, can be found in the FDA’s Recognized Consensus Standards database.
The FDA has 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.
The FDA continues to monitor the safety and effectiveness of LASIK while engaging with patients, physicians and other stakeholders to improve the quality of information available to the public about LASIK. This page will be updated as new information on LASIK becomes available.