Introduction
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) [cit1]. 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 [cit2]. 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 [cit3] 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 [cit4].
Citations
| [cit1] | Keratectasia rate of 0.66%. See Section B5 |
| [cit2] | Adverse event rate of 20.0%. See Sections A1, A2 |