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Prior to the introduction of LASIK, cataract surgery was the bread and butter of the ophthalmologist's practice. In the United States in the 1990s, Medicare made a series of cuts to cataract surgery reimbursements. In response, eye surgeons, scrambling for a new income stream, turned to the more lucrative practice of LASIK.

“Refractive surgery may yet live up to its early promise and support the rest of the practice -- the way cataract surgery used to.”

  1. -Dr. Charles Casebeer, Senior Medical Monitor for early clinical trials of LASIK.

"Many thousands of eyes have been damaged beyond repair by LASIK devices since the 1990s. Approximately 700,000 eyes will receive refractive surgery with LASIK devices by the end of year 2011. Thus, more than four thousand six hundred (4,630) are projected to face blindness due to surgically thinned and bulging corneas (keratectasia).

This is an addition to the many thousands of LASIK patients already suffering from keratectasia. In addition, more than 70,000 LASIK patients (140,000 eyes) will suffer by the end of 2011 with persistent adverse effects including but not limited to night vision disturbances, dry eye, glare, and halos.

These LASIK-induced adverse events have occurred from using both early and late model LASIK technologies. Also, upwards of 43 percent of LASIK patients will be wearing corrective lenses 6 to 12 months after surgery and in about 7 years fifty-five percent will be unhappy with their vision and the number of eyes that lost 2 or more lines of visual acuity will have doubled.

Manufacturers and their collaborators (including but not limited to clinics, refractive surgeons, and agents) withheld and distorted safety and effectiveness data submitted to the Food and Drug Administration (FDA) so that LASIK devices would appear to have:


•    A FDA-acceptable adverse event rate of ≤1%, rather than the true rate of at least 20%

•    Only temporary adverse effects when, in fact, some persist for 6 months to many years

•    >90% effectiveness when the true rate is approximately 57%


FDA decision-making on LASIK devices was dominated by LASIK surgeons working hand-in-glove with LASIK manufacturers. Data recently brought to light exposes this partnership for what it was: a classic example of the fox guarding the henhouse, wherein the primary arbiters of safety and effectiveness of LASIK devices were the device manufacturers and its collaborators."


-- Dr. Morris Waxler

Oogziekenhuis OMC Amsterdam

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