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Recent Higher Order Aberration Medical Journal Articles...

Higher Order Aberration Laser Approval Limitation

Advisory memorandum regarding unsubstantiated claims by Lasik laser manufacturers.

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Patient advocacy issues advisory warning laser manufacturers and physicians regarding claims of wavefront custom Lasik surgery correction.  

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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