FDA LASIK information FAQ
Please select your question from the following list of FAQs:
The FDA website provides the following information about LASIK:
The cornea is a part of the eye that helps focus light to create an image on the retina. It works in much the same way that the lens of a camera focuses light to create an image on film. The bending and focusing of light is also known as refraction. Usually the shape of the cornea and the eye are not perfect and the image on the retina is out-of-focus (blurred) or distorted. These imperfections in the focusing power of the eye are called refractive errors. There are three primary types of refractive errors: myopia, hyperopia and astigmatism. Myopia is also known as nearsightedness since it is difficult to see distant objects clearly. Persons with hyperopia have more difficulty seeing near objects clearly than distant objects. This condition is also known as farsightedness. Astigmatism is a distortion of the image on the retina usually caused by irregularities in the cornea. Combinations of myopia and astigmatism or hyperopia and astigmatism are common. Glasses or contact lenses are designed to compensate for the eye's imperfections. Surgical procedures aimed at improving the focusing power of the eye are called refractive surgery. In LASIK surgery, precise and controlled removal of corneal tissue by a special laser reshapes the cornea changing its focusing power.
What the FDA regulates:
In the United States, the Food and Drug Administration (FDA) regulates the sale of medical devices such as the lasers used for LASIK. 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 safe and effective for a particular use, the "indication." Once the FDA has approved a medical device, a doctor may decide to use that device for other indications if the doctor feels it is in the best interest of a patient. The use of a device for other than its FDA-approved indication is called "off-label use." The FDA does not regulate the practice of medicine. The first refractive laser systems approved by FDA were excimer lasers for use in PRK to treat myopia and later to treat astigmatism. However, doctors began using these lasers for LASIK (not just PRK), and to treat other refractive errors (not just myopia). Over the last several years, LASIK has become the main surgery ophthalmologists use to treat myopia in the United States. Only recently have some laser manufacturers gained FDA approval for laser systems for LASIK to treat myopia, hyperopia and astigmatism and for PRK to treat hyperopia and astigmatism.