FDA proposes checklist to inform patients of LASIK surgery risks

Regulatory NewsRegulatory News
| 28 July 2022 | By Ferdous Al-Faruque 

The US Food and Drug Administration (FDA) on Wednesday released draft guidance on conveying the potential risks with Laser-Assisted In Situ Keratomileusis (LASIK) laser products in labeling to better convey these risks to consumers.
On 27 July, FDA published a draft guidance titled Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations. As more potential side-effects of LASIK treatments have become known over the years, the agency hopes updating labeling recommendations will better help patients understand potential risks.
"It is important to provide patients with comprehensive labeling that clearly describes the risks involved with LASIK surgery, including potential adverse effects such as dry eye, pain and discomfort, and visual symptoms," said Jeff Shuren, director of FDA's Center for Devices and Radiological Health. "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. The draft guidance is designed to support discussions that patients should have with their eye care providers about the benefits and risks of LASIK to help them make informed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."
FDA held an advisory committee meeting of its Ophthalmic Devices Panel in April 2008 on what should be included in LASIK product labeling to ensure patients are well-informed about treatment risks. At the meeting, advocacy groups highlighted the importance of better risk communication. Since then, regulators have continued to gather additional data on potential adverse events associated with the products.
“Clinical and scientific knowledge about these events and symptoms has increased since the time of the last advisory committee meeting,” FDA noted. “FDA has diligently collaborated with external experts on research efforts, including focus groups, to better characterize risks to ensure that the recommended labeling discussed in this guidance addresses the concerns uncovered in this collaboration and that risk information is communicated in an understandable format.”
FDA makes a number of recommendations in the draft guidance for what should be included in the labeling of Lasik products including general information about the surgical procedure; indications for use; benefits;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.
The draft guidance also includes a proposed patient decision checklist that physicians can distribute to patients before treatment.
“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,” FDA said. “It also proposes that the patient and physician sign the checklist to acknowledge it was read and discussed.”
FDA notes the proposed guidance is the result of collaboration with external experts including the National Eye Institute (DEI) and the Department of Defense (DoD) with whom the agency researched risks of LASIK surgery as part of the LASIK Quality of Life Collaboration Project. The agency says that research led to the creation of the Patient-Reported Outcomes with LASIK PROWL Symptoms and Satisfaction (PROWL-SS), questionnaire, qualified through FDA's Medical Device Development Tools (MDDT) program.
Stakeholders can comment on the draft guidance on www.regulations.gov under docket no. FDA-2022-D-1253 until 26 October.


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