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LASIK and the FDA
LASIK is a vision correction procedure that uses lasers to reshape the cornea. It and similar procedures like PRK, LASEK, and Epi-LASIK are not actually governed by the Food and Drug Administration (FDA). Instead, the FDA has the power to approve the devices that are used in LASIK. Even without FDA approval, doctors have the right to use lasers to perform LASIK and other procedures, but FDA-approval confirms the safety and efficacy of the lasers used to perform the procedure.
Limits of FDA's Authority
The FDA has authority over the marketing and sale of medical devices in the United States. It also has the authority to monitor the safety of medical devices and issue public warnings or request recalls in the event a device appears to be unreasonably safe. The FDA uses the following methods of ongoing safety evaluation of all medical devices:
- MedWatch--a system technically known as the Safety Information and Adverse Event Reporting Program, which collects reports of potentially dangerous devices from manufacturers, doctors, and patients. If you have experienced an adverse consequence as a result of a medical device, you can report it here.
- SightNet--essentially a chat room or clearinghouse for ophthalmologists at participating locations to discuss professional concerns about potential safety issues.
In addition, the FDA opens a digital docket for testimony relevant to ongoing investigations into technologies and practices. Currently, the FDA is investigating LASIK, and in September 2008, it opened a docket that is open to public comment through September 2009. You can view the LASIK testimony docket here.
The FDA does not have the power to do any of the following:
- Tell a doctor how to conduct his or her practice
- Control prices for procedures
- Force doctors to give information to patients
- Make recommendations to particular doctors or practices
- Rate medical devices on a scale from best to worst, or safest to least safe, or any other system
The FDA seeks to make available as much information as possible, but it is still your responsibility as a patient considering a procedure to seek out and utilize that information in the interest of your safety.
FDA-Approved Lasers
The following lasers have been approved for use in laser vision correction by the FDA:
- Mel 80 Excimer Laser System By Zeiss approved August 11, 2006 for stable myopia less than or equal to 7.0 diopters with or without astigmatism of less than or equal to 3.0 diopters
- WaveLight Allegretto WAVE approved October 7, 2003, but was updated to allow treatment of stable myopia up to12.0 diopters with or without astigmatism up to 6.0 diopters, and stable hyperopia up to 6.0 diopters with or without astigmatism up to 5.0 diopters.
- TECHNOLAS 217 A Excimer Laser System approved February 23, 2000 for correcting stable myopia up to 12.00 diopters in some circumstances with up to 3.0 diopters of astigmatism and stable hyperopia up to 4.00 diopters with astigmatism up to 2.00 diopters
- VISX Excimer Laser System approved March 27, 1996 first for PRK, then expanded to include LASIK treatment of up to 11.0 diopters of stable myopia with up to 3.0 diopters of astigmatism and stable hyperopia up to 3.0 diopters
- EC-5000 Excimer Laser System approved December 17, 1998 first for PRK, then for LASIK treatment for stable myopia up to 14.0 diopters with up to 4.0 diopters of astigmatism and stable hyperopia up to 5.0 diopters with up to 2.0 diopters of astigmatism.
- LADARVision 4000 Excimer Laser System approved November 2, 1998, first for PRK, then expanded to include LASIK of stable myopia up to 9.0 diopters with up to 3.0 diopters of astigmatism and stable hyperopia up to 6.0 diopters with up to 6.0 diopters of astigmatism.
If you are considering LASIK or another refractive laser surgery, ask your doctor about the laser being used.
If you have a problem with your LASIK procedure that your ophthalmologist is unable to resolve, you should report it to the FDA using the MedWatch system. This type of reporting can help the administration identify systemic errors associated with particular lasers or practices.
If you would like to talk to a doctor about the safety and effectiveness of LASIK or a similar procedure, make an appointment with a local ophthalmologist today.
