January 2004 - It has come to our attention that patients are
commonly being told the
wavefront-guided excimer laser used for custom
Lasik,
All-Laser Lasik,
PRK,
LASEK, and
Epi-Lasik surgery is approved by the US Food and Drug Administration
(FDA) to treat and correct high order aberrations (HOA), defined
as those optical aberrations measured and expressed in Zernike polynomials
level three and greater.
A review of the relevant documentation will find the FDA approvals
do not include language that supports the contention that
wavefront-guided excimer lasers are FDA approved to correct HOA.
Our organization’s goal is to promote full and truthful communications
between physician and patient in a positive and cooperative environment
where patients are appropriately and accurately informed. In the
interest of the dissemination of accurate information, we respectfully
ask that all physicians and manufacturer representatives carefully
compare the FDA-approved labeling for the proposed laser system
with current patient information materials to affirm that the information
distributed accurately reflects FDA approval status regarding high
order aberration correction for your particular laser.
HOA Advisory Memorandum
If you are ready to choose a doctor to be evaluated for conventional
or wavefront custom Lasik, All-Laser Lasik, PRK, LASEK, Epi-Lasik,
NearVision CK,
RLE, or any
refractive surgery procedure, we highly recommend you consider
a doctor who has been evaluated and certified by the USAEyes
nonprofit organization. Locate a USAEyes Evaluated & Certified
Lasik Laser Eye Surgery Doctor.
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