FDA releases draft guidance on LASIK patient labeling recommendations
AUG 09, 2022
Comprehensive Ophthalmology, Refractive Mgmt/Intervention
On July 27, 2022, the US Food and Drug Administration (FDA) issued a draft guidance for content and formatting of patient labeling information for laser-assisted in situ keratomileusis (LASIK) laser devices. The FDA had received feedback that more information needs to be made available, including indications for LASIK use, details about the surgical procedure, benefits and risks, and what to expect before, during, and after surgery.
The draft guidance also proposes adding a patient decision checklist to the patient labeling information, which can be given to patients prior to the procedure so they can review it on their own and with their surgeon. This checklist would include details on who would be a good candidate for LASIK as well as the long-term risks of the procedure.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, noted that the proposed recommendations, which were developed after input from patients and other stakeholders, “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 added that the recommendations “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The FDA is seeking comments on this draft guidance from various stakeholders, including ophthalmic surgeons, other health care providers, and patients. Feedback can be submitted online until October 26, 2022.