Waxler Regulatory Consultancy LLC 1/6/11 2 of 32

CITIZEN PETITION

Waxler Regulatory Consultancy, LLC submits this petition to the United States Food and Drug Administration (FDA) under 21 Code of Federal Regulations (CFR) § 10.30, and sections 201, 301, 510, 513, 519, and 520 of the Federal Food, Drug, and Cosmetic Act (FDCA) to ask FDA Commissioner Dr. Margaret Hamburg to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for LASIK eye surgery. Data are provided as factual grounds in support of this petition, and requests fall under FDA jurisdiction under 21 CFR, Part 5.10. The urgency and enormity of the threat of LASIK devices to public health and safety indicate further need for involvement of FDA’s Office of Criminal Investigation (OCI), the House Energy and Commerce Committee's oversight and investigations subcommittee and other congressional leaders in this matter. 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).

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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.

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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

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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.

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ACTION REQUESTED

I, Morris Waxler

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, am the former Branch Chief in charge of FDA approvals of LASIK devices between 1996-2000. I request FDA commission er, Dr. Margaret Hamburg, take the following actions:

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Withdraw FDA approval (PMA) for all LASIK devices

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Issue a Public Health Advisory with a voluntary recall of LASIK devices

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FACTUAL GROUNDS

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

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A FDA-acceptable adverse event rate of

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1%, rather than the true rate of at least 20%

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

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o

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

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