|
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 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.
|
