SILVER SPRING, Md. , July 27, 2022 /PRNewswire/ — Today, the U. S. Food plus Drug Administration issued a draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits and risks of LASER EYE SURGERY devices.
“It is important to provide patients with comprehensive labeling that obviously describes the particular risks involved with LASIK surgery, including potential adverse effects such as dry eye, pain and discomfort, and visual symptoms, ” said Jeff Shuren , M. D., director associated with the FDA’s Center for Devices and Radiological Health. “These proposed labeling recommendations, based on extensive consultation with stakeholders and individuals, are intended to present information about LASIK in language that is easy in order to read plus understand and include images that convey visible symptoms that could occur following LASIK. The draft guidance is designed to support discussions that will patients should have with their eye care providers about the benefits and dangers of LASIK to help them make informed decisions before proceeding with the surgical treatment. ”
LASIK is an outpatient surgical procedure that permanently reshapes the cornea to change the way the particular eye focuses light rays onto the retina at the back of the eye. LASIK surgery is intended to correct common vision problems like nearsightedness, farsightedness, and astigmatism plus to reduce a person’s dependency upon eyeglasses and contact lenses.
The particular draft assistance ” Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations , inch details the particular FDA’s suggested recommendations for the content plus format of patient marking for LASER EYE SURGERY devices, including general details about the medical 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 info. In addition, the draft guidance proposes the inclusion of a patient decision checklist as part of the patient labeling details that physicians provide in order to their sufferers prior to the process. To make sure the individual decision checklist is clearly understood by patients, the particular proposed register includes, among other information, who is the good candidate for LASIK, what in order to expect after surgery, and a summary associated with long-term dangers of the procedure. It also offers that the particular patient plus physician sign the directory to acknowledge it was read and discussed.
The FOOD AND DRUG ADMINISTRATION collaborated along with external experts on research efforts that will informed the recommendations within the write guidance. The agency, in collaboration using the National Eye Institute and the Department of Defense, conducted research included in the LASIK Quality of Life Collaboration Project to assist better understand the possible risk associated with problems that can occur right after LASIK. This project led to the development of the Patient-Reported Outcomes with LASIK PROWL Symptoms and Satisfaction (PROWL-SS), questionnaire, qualified through the particular FDA’s Medical Device Development Tools (MDDT) program.
By issuing draft guidance for public comment, the FDA is encouraging feedback on the proposed labeling suggestions from patients, health care providers and stakeholders. The FDA will continue to monitor the latest scientific data related to LASER EYE SURGERY and work with professional medical societies plus patient advocacy groups to assist ensure that will risk info about LASIK devices will be disseminated to patients, as new details becomes obtainable.
The particular FDA, an agency within the U. H. Department of Health and Human Services, protects the particular public wellness by assuring the safety, effectiveness, plus security associated with human and veterinary drugs, vaccines and other biological products for human use, plus medical devices. The agency also is usually responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, items that give off electronic radiation, and for regulating tobacco products.
SOURCE U. T. Food plus Drug Management