What is LASIK Eye Surgery?

LASIK (Laser-Assisted In Situ Keratomileusis) is a surgical procedure that can reduce a person's dependency on glasses or contact lenses. The procedure permanently changes the shape of the cornea, which is the delicate clear covering on the front of the eye. In order to have clear vision, the eye's cornea and lens must bend (refract) light rays properly, so that images are focused on the retina. If light rays are not clearly focused, blurry vision can result.

LASIK eye surgery is performed most often on people who have nearsightedness (myopia). LASIK is an outpatient surgical procedure that normally takes 10 to 15 minutes for each eye.

How the FDA Regulates LASIK

In the United States, the U.S. Food and Drug Administration (FDA) regulates the sale of medical devices, including lasers used for LASIK. A person or company must seek FDA approval before legally selling a medical device in the U.S. In order to gain approval, the applicant must present evidence that the device is reasonably safe and effective for a particular use (the "indication"). Afterward, a doctor may decide to use an approved medical device for other indications if in the best interest of the patient. However, the FDA does not regulate such use ("off-label use") or the practice of medicine.

Therefore, the FDA does not have the authority to:

• Regulate a doctor's practice - the FDA does not tell doctors what to do when running their business or what they can or cannot tell their patients.

• Set the amount a doctor can charge for LASIK eye surgery.

• "Insist" that the patient information booklet from the laser manufacturer be provided to the potential patient.

• Make recommendations for individual doctors, clinics, or eye centers - the FDA neither maintains nor has access to a list of doctors performing LASIK eye surgery.

• Conduct or provide a rating system on any medical device it regulates.