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| Patient advocacy issues advisory warning laser manufacturers
and physicians regarding claims of wavefront custom Lasik
surgery correction. |
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January 2004 - It has come to the attention of USAEyes that patients are
commonly being told the wavefront-optimized excimer laser used for custom Lasik, Bladeless Lasik, PRK, LASEK, and Epi-Lasik surgery is approved by the US Food and Drug Administration
(FDA) to treat and correct higher 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. USAEyes has issued a patient advisory memorandum calling for the cessation of unsupported claims, see HOA Advisory Memorandum.
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.
Looking For Best Lasik Surgeon?
If you are ready to choose a doctor to be evaluated for conventional
or custom wavefront Lasik, Bladeless Lasik, PRK, or any refractive surgery procedure, we recommend you consider a doctor who has been evaluated and certified by the USAEyes nonprofit organization.
Locate a USAEyes Evaluated & Certified Lasik Doctor.
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