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FAQs (Frequently Asked Questions)
Q: Can you refer me to a good LASIK surgeon in my
area?
A: 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.
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.
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.
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