| FDA
> CDRH > LASIK
> FAQs (Frequently Asked Questions)
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.
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).
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.
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.
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.
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.
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.
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.
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.
Q: Can you send me more information or respond to my concern?
A: No. The most current information we have about LASIK is on this
website and we update it routinely. We do not have the resources to
respond directly to patient concerns or questions. We encourage you to
discuss these matters with your doctor.
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.
Updated March 6, 2008
(Some Photos Copyright © 2000, Photodisc, Inc.) |
Report a Problem