Citizen Petition to withdraw LASIK approval

About

• Dr. Waxler’s MSNBC Interview Video
• Help by Signing
• Thank You
  • Delivery Confirmations
    • 1. FDA Commissioner, Dr. Margaret Hamburg, M.D.
    • 2. Doug Wood, Acting Director, FDA, Division of Postmarket Surveillance.
    • 3. Director, FDA, Center for Devices and Radiological Health, Division of Opthalmic, Neurological and ENT Devices
    • 4. Steven Silverman, Director, Center for Devices and Radiological Health, Office of Compliance

Waxler Regulatory Consultancy LLC Citizen Petition

• Letter to Division of Dockets Management, Food and Drug Administration
• Introduction
• I. Action Requested
• II. Factual Grounds
  • A. PMA Applicants Withheld and Distorted Safety Data In Submissions to FDA
    • 1. Falsified and Misrepresented Data in Submissions to FDA
    • 2. Manufacturers Pressured FDA to Not Count Certain Adverse Events.
    • 3. Manufacturers Withheld Safety Data
    • 4. Manufacturers Distorted Effectiveness of LASIK Device
  • B. LASIK Creates Sick Corneas From Normal Ones
    • 1. LASIK flap never completely heals
    • 2. LASIK permanently weakens the cornea
    • 3. LASIK severs corneal nerves, causing neuropathic dry eyes
    • 4. LASIK Devices Induce Progressive Pathology in the Cornea
    • 5. LASIK Causes Keratectasia, a Sight-Threatening Disorder
    • 6. LASIK Induces Corneal Distortions
    • 7. Persistent post–LASIK Loss of Contrast Sensitivity in Dim Light
    • 8. LASIK is Unstable and Regresses
    • 9. LASIK Creates the Need for Additional Eye Care
      • a. LASIK Increases Risk of Undiagnosed Glaucoma
      • b. LASIK Increases risk of Poor Outcome Following Cataract Surgery
    • 10. Newer LASIK Devices Cause the Same Permanent Corneal Damage as Older Models.
• III. Public Health Alert - Key Warnings
• IV. Environmental Impact
• V. Economic Impact
• VI. Certification
• Appendix