LASIK surgery and FDA's role

The Federal Food and Drug Administration regulates the sale of medical devices in the United States and monitors the safety of all regulated medical devices.

FDA approves the safety and effectiveness of Excimer Laser and other devices independent of any other product, but does not regulate the Medical practice.

The link between LASIK surgery and the Federal Food and Drug Administration is very different from what many people think. The FDA regulates the sale of medical devices such as the lasers used for LASIK called Excimer Laser. Before a medical device can be legally sold in the U.S, the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use.

Strictly speaking, the FDA does not regulate doctors nor procedures but only the safety and sale of the medical devices doctors in the United States use. The FDA does not have authority over what claims a doctor can make regarding LASIK surgery nor what a doctor can charge for the procedure. It does not conduct nor provide a ratings system on LASIK devices, and it does not make recommendations to patients seeking the procedure in regards to the respective merit or ethics of individual doctors, clinics, or eye centers.

Nevertheless, the FDA is not silent on the issue of LASIK surgery. In April of 2008, the FDA convened a panel to discuss complaints regarding misleading advertising and the limitations and risks of the procedure. As a result, today on the LASIK portion of its website the FDA offers sound advice to help potential patients choose a reputable doctor as well as weigh the perceived benefits against the possible risks of corrective surgery. In choosing an eye doctor to perform LASIK surgery, the Federal Food and Drug Administration encourages potential patients to educate themselves not only in regards to the surgeon's experience and reputation, but also regarding the specific laser equipment that the surgeon uses.

Since potential risks vary from device to device, patients are urged to ask their physician for and read the manufacturer-provided, device-specific handbook on the LASIK device the doctor will be using. The doctor should be willing to relay his/her personal experience with that device and frankly discuss both successes and complications that he/she has experienced. In addition, the FDA warns that advertising claims that appear too good to be true (such as "20/20 vision guaranteed!") are most likely not.

FDA Advises

The FDA also advises those seeking corrective laser eye surgery to educate themselves regarding the risks. While it reports that most patients are quite satisfied with the outcome of their surgery, it is also careful to remind potential patients that all medical procedures carry certain inherent risks. Potential LASIK complications include loss of vision, loss of night vision, loss of low contrast clarity, double vision, halo vision, or persistently dry eyes. In addition, the FDA warns that a less than complete percentage of patients achieve 20/20 vision post-surgery and thus may still require the use of glasses or contacts. Finally, the FDA reminds patients that as LASIK is still a new technology and as such, long-term data on safety and effectiveness is simply not yet available.

Ongoing involvement with LASIK devices

The FDA first granted approval for a LASIK device in July of 1998 and since that time a total of twenty-seven additional laser devices have received FDA approval specifically for LASIK surgeries. The FDA is continually and actively involved in the ongoing safety and effectiveness of these (and future) devices, and looks not only to professional studies but to the public’s input in these efforts.

In 2009 the Federal Food and Drug Administration launched the LASIK Quality of Life Project, a three-year, three-phase study intended to better identify, understand, and communicate the various factors that affect patients’ quality of life following a LASIK surgical procedure. At that time, acting director of the FDA’s Center for Devices and Radiological Health Dr. Jeffrey Shuren stated that “This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure.”

In order to facilitate communication with the public at large, the FDA continually monitors the safety of all regulated medical devices through its MedWatch program. Those patients who have had a negative experience with a LASIK device or have been injured by the procedure should file a voluntary report with the FDA by calling 1-800-FDA-1088. Patients may also file online at the following link here!

Lastly, in 2009 the FDA reopened its open docket at www.regulations.gov and is again soliciting both positive and negative comments from LASIK patients through November 15, 2010. Individuals may submit comments for public record at www.regulations.gov and clicking on “submit a comment.” Those without internet access are requested to send written documents to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

All submissions, whether electronic or written, are to be clearly identified with the document number FDA-2008-N-0488. All comments are available for the public record and may be posted at the FDA’s website for public viewing.

Page updated Sep 02, 2010