Medical Devices

LASIK - FAQs (Frequently Asked Questions)


Q: Can you refer me to a good LASIK surgeon in my area?

A: Refer to the Other Resources section of this site. You may want to contact the organizations listed there for additional information. While FDA regulates medical devices and drugs, FDA does not regulate the practice of medicine and does not have a registry of doctors. FDA does not know of any government agency that can provide a referral for any medical procedure. You may want to go to your library and see if there is a local community services magazine that may provide comparison information of services for doctors in your area.

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Q: How do I report a bad experience or who do I notify about a 'bad' doctor?

A: If you had a bad experience or sustained an injury, you should file a voluntary MedWatch report (1-800-FDA-1088) to the FDA. Also, you could contact your state medical licensing board and file a complaint with them. In addition, you could contact your state health department or consumer complaint organization (e.g., Better Business Bureau).

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Q: How much does LASIK cost?

A: The FDA regulates the safety and effectiveness of medical devices for their intended use. The FDA does not regulate the marketing of or any fees associated with the use of that product. Again, you may want to go to your library and see if there is a local community services magazine that may provide comparison information of services for doctors in your area.

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Q: How can I find out if a particular laser has been approved to treat my refractive error (nearsightedness, farsightedness and/or astigmastism)?

A: You can find approved devices, their approval date, and a synopsis of the approved indications on the FDA-Approved Lasers page.

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Q: If the laser I am interested in has not yet been approved for a particular indication, how can I find out when it will be approved?

A: Confidentiality restrictions prohibit FDA from commenting on the status of a device under regulatory review, but you can try asking the laser company for this information.

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Q: Which laser is the best for treating my refractive error?

A: FDA does not provide comparisons between refractive lasers. FDA approves the safety and effectiveness of a device independent of any other product. However, you are encouraged to review the approval documents to assess the capabilities of specific laser systems and make your own comparisons. The approval number for each laser on the FDA-Approved Lasers page is linked to these documents, which provide additional, detailed information about the clinical trial results and indications for use. Discuss any concerns you may have with your doctor.

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Q: How does wavefront LASIK compare to conventional LASIK?

A: Wavefront adds an automatic measurement of more subtle distortions (called higher order aberrations) than just nearsightedness, farsightedness, and astigmatism corrected by conventional LASIK. However, these “higher order aberrations” account for only a small amount (probably no more than 10%) of the total refractive error of the average person’s eye. Conventional LASIK increases higher order aberrations. Although wavefront-guided treatments attempt to eliminate higher order aberrations, results from the clinical studies have shown that the average aberrations still increase, but less than they do after conventional LASIK. In a few studies comparing wavefront-guided LASIK to conventional LASIK, a slightly larger percentage of subjects treated with wavefront LASIK achieved 20/20 vision without glasses or contact lenses compared to subjects treated with conventional LASIK. Patient selection (“When is LASIK not for me?”) and the experience and competence of the surgeon are still the most important considerations.

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Q: What is “All-Laser LASIK” and how does it compare to traditional LASIK surgery?

A: The difference between traditional LASIK and “All-Laser LASIK” (also known as “Bladeless LASIK”) is the method by which the LASIK flap is created. In “All-Laser LASIK”, a laser device called a laser keratome, is used to cut a corneal flap for LASIK surgery. This is a newer method to create a corneal flap than the traditional method of using a microkeratome, a mechanical device with a blade. There is no absolute agreement among eye surgeons on the better choice for flap creation. Some of the factors a surgeon considers when choosing a preferred method of flap creation during LASIK are as follows:

  • Quality of vision
  • Rate of complications
  • Pain during and after surgery
  • Precision of flap size and thickness
  • Time to recovery of vision
  • Expense

Discuss with your doctor any questions and concerns you have about how they chose their preferred method of flap creation.

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Q: What percentage of patients attain 20/20 vision or better without glasses or contacts?

A: Data in the Approval Orders and related documents summarizes the outcomes from the clinical trials submitted to the FDA for each approved device. Links to these documents are included on the FDA-Approved Lasers page.

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Q: Can I use information from the FDA LASIK website?

A: Yes. Information on this website can be used freely by the public. Any use on other websites or in publications should be properly cited.

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(Some Photos Copyright © 2000, Photodisc, Inc.)

Page Last Updated: 06/09/2014
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