January 6, 2011
Division of Dockets Management Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane, rm. 1061 Rockville, MD 20852
Dear Sir or Madam:
Waxler Regulatory Consultancy LLC submits the attached Citizen Petition under Sections 201, 301, 510, 513, 519, and 520 of the Food Drug and Cosmetic Act and 21 Code of Federal Regulations to request the Commissioner of Food and Drugs to withdraw FDA approval (PMA) for all LASIK devices and issue a Public Health Advisory with a voluntary recall of LASIK devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for LASIK eye surgery.
Please contact me if you have questions.
Respectfully submitted,
Morris Waxler, Ph.D. President Attachment