Guide on LASIK Patient Labeling Recommendations
FDA has issued a draft guidance to help ensure that information is available to patients and health care professionals about the benefits and risks of LASIK devices, which are used in vision correction (e.g., nearsightedness, farsightedness, and astigmatism) surgeries. Interested parties can comment on the guidance until 10/26.
The guide is intended make sure patients and physicians understand potential risks from undergoing such surgeries, including potential adverse effects such as dry eye, pain and discomfort, and visual symptoms, CDRH director Jeff Shuren said in a release. “These proposed labeling recommendations, based on extensive consultation with stakeholders and patients, are intended to present information about LASIK in language that is easy to read and understand and include images that convey visual symptoms that could occur following LASIK,” he said. “The draft guidance is designed to support discussions that patients should have with their eye care providers about the benefits and risks of LASIK to help them make informed decisions before proceeding with the surgery.”
The draft guidance, “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations,” provides recommendations for the content and format of patient labeling for LASIK devices, including general information about the surgical procedure; indications for use; benefits; procedure alternatives; contraindications, warnings and precautions; risks; what to expect before, during and after surgery; clinical study information; and manufacturer contact information. It also proposes including a “patient decision checklist” that physicians can provide to their patients prior to the procedure. “To ensure the patient decision checklist is clearly understood by patients, the proposed checklist includes, among other information, who is a good candidate for LASIK, what to expect after surgery, and a summary of long-term risks of the procedure,” the agency says, adding that the checklist should be signed by both patients and physicians.
FDA says it collaborated with National Eye Institute and the Department of Defense to develop the labeling recommendations. The groups earlier conducted research as part of the LASIK Quality of Life Collaboration Project to help better understand the potential risk of problems that can occur after LASIK. The project resulted in the patient-reported outcomes questionnaire “LASIK PROWL Symptoms and Satisfaction (PROWL-SS).”
Adverse events related to LASIK and other laser eye surgeries have been a contentious issue for years. After more than a decade of stonewalling injured patients’ complaints about adverse reactions, CDRH in 2018 lifted their hopes for a change of heart at a one-hour meeting — then dashed them five days later in a statement that doubled down on the agency’s existing position: LASIK is safe and effective for nearly everyone. At issue in the long-simmering controversy is the level of adverse effects that should be tolerated — FDA accepts the industry claim of less than 2% while the patient group cites PMA data showing rates as high as 20%, pointing out that for a medically unnecessary, elective cosmetic procedure it should be close to 0%. LASIK marketers promote LASIK as an alternative to wearing glasses.
Morris Waxler, the retired CDRH branch chief who approved the LASIK indication for the devices and led the patient group that met with CDRH, said the devices produce “2% catastrophic problems and 20% chronic daily pain and vision distortions.” FDA is “trapped by the facts and owned by industry,” he told FDA Webview in an email after the meeting.
In 2019, Waxler told CBS News that approving the device was a mistake and LASIK should be taken off the market. “I reexamined the documentation … and said, ‘Wow, this is not good,” Waxler told the network. He said his own analysis of industry data shows complication rates between 10% and 30%.