On July 27, 2022, the FDA issued the draft guidance Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations.
This draft guidance recommends proposed content and formatting for patient labeling information for LASIK devices. It is important for people considering LASIK to have clear and understandable information on the benefits and risks of the surgery to help inform their decision on whether to get LASIK. These recommendations, when finalized, are intended to help ensure physicians can share and patients can understand information about the benefits and risks of LASIK devices. Further, this information is intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of LASIK devices that may uniquely pertain to individual patients.
Submit comments under docket number FDA-2022-D-1253 at www.Regulations.gov, by October 26, 2022.
LASIK is a surgical procedure intended to reduce a person's dependency on glasses or contact lenses. The goal of this Web site is to provide objective information to the public about LASIK surgery. See other sections of this site to learn about what you should know before surgery, what will happen during the surgery, and what you should expect after surgery. There is a glossary of terms and a checklist of issues for you to consider, practices to follow, and questions to ask your doctor before undergoing LASIK surgery. This web site also provides information on FDA’s role in LASIK surgery, FDA’s current LASIK activities, and FDA-approved lasers for LASIK.
LASIK stands for Laser-Assisted In Situ Keratomileusis and is a procedure that permanently changes the shape of the cornea, the clear covering of the front of the eye, using an excimer laser. A mechanical microkeratome (a blade device) or a laser keratome (a laser device) is used to cut a flap in the cornea. A hinge is left at one end of this flap. The flap is folded back revealing the stroma, the middle section of the cornea. Pulses from a computer-controlled laser vaporize a portion of the stroma and the flap is replaced. There are other techniques and many new terms related to LASIK that you may hear about.
Below is a video that summarizes some risks of LASIK surgery and other important information. The video includes images of common visual problems that a LASIK patient may see. Please be sure to visit the other sections of this web site to get more information.