LASIK and the FDA

    CHICAGO, IL, June 01, 2012 /24-7PressRelease/ -- LASIK eye surgery is a Laser Vision Correction procedure that uses targeted laser energy to reshape your eye's cornea, improving your vision and eliminating (or severely reducing) your dependence on corrective eyewear. The LASIK procedure - along with similar surgeries like PRK, LASEK, and epi-LASIK - are not governed by the Food and Drug Administration (FDA); however, the FDA does have the power to approve the medical devices that are used in LASIK surgery.

Eye surgeons are legally able to use lasers that are not approved by the FDA, but FDA approval ensures the safety and effectiveness of certain lasers in performing these complex procedures.

The Limitations of the FDA's Authority

In the United States, the FDA has authority over the sale and marketing of all medical devices. The FDA is able to request recalls and/or issue public warnings for any device that is judged unreasonably safe. In its ongoing safety evaluation of medical devices, the FDA uses two specific methods:

- SightNet - This program gives ophthalmologists a chance to meet at participating locations to discuss their professional concerns about safety issues relating to certain medical devices.

- MedWatch - This system is also known as the Safety Information and Adverse Event

Reporting Program. It is designed to collect reports regarding potentially dangerous medical devices from doctors, patients, and manufacturers. If someone has suffered an injury or adverse consequence because of a medical device, they are encouraged to report it to MedWatch.

The FDA does not have the power to control pricing for procedures, tell an eye doctor how to conduct their practice, force ophthalmologists to give information to their patients, or rate medical devices on a scale from best to worst. While the FDA seeks to make as much information available as possible, it is still the patient's responsibility to research the safety of any given procedure.

FDA-Approved Lasers Used for Laser Vision Correction

The lasers listed below have all been approved by the FDA for use in laser vision correction procedures:

- WaveLight Allegretto WAVE
- Mel 80 Excimer Laser System (by Zeiss)
- VISX Excimer Laser System
- TECHNOLAS 217 A Excimer Laser System
- LADARVision 4000 Excimer Laser System
- EC-5000 Excimer Laser System

The vast majority of all refractive laser procedures in the United States are performed on the Visx Excimer Laser System, used by Dr. Mark Golden. If you are considering LASIK eye surgery - or any other type of refractive vision correction - be sure to ask your eye doctor about the specific type of laser they use. If your ophthalmologist is unable to resolve a problem that you encounter with your LASIK procedure, the FDA encourages you to report it to the MedWatch system. This helps the FDA identify specific errors that are associated with particular laser systems or practices.

If you would like further information about LASIK eye surgery, please visit the website of the experienced Chicago eye surgeon Dr. Mark Golden at Doctors For Visual Freedom at www.doctorsforvisualfreedom.com.

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