Should Controversial FDA Draft Guidelines for LASIK Eye Surgery be withdrawn?
Although the FDA guidelines were needed, the document appeared to be one-sided, focusing on the risks that will frighten patients from undergoing the procedure.
December 11, 2022
The U.S. Food and Drug Administration (FDA) approved LASIK eye surgery more than 25 years ago as a safe (albeit expensive) alternative to glasses and contact lenses. Now the FDA is recommending new guidance for people considering the procedure that better details LASIK's risks and potential complications.
However, every year, more than 500,000 Americans undergo the LASIK procedure, and surveys suggest the vast majority are satisfied with the results.
FDA officials say less than 1 percent of people who have LASIK surgery have long-term consequences.
The American Academy of Ophthalmology recommends patients talk with their ophthalmologist to understand the potential risks and to ensure they are a good candidate for surgery.”
By US Food and Drug Administration
On October 7, 2022, the FDA announced the comment period for the draft guidance Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations, published on July 28, 2022, is extended by 30 days and will close November 25, 2022.
This draft guidance recommends proposed content and formatting for patient labeling information for LASIK devices.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.
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.
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