LifeAfterLasik.com Reports Dr. Morris Waxler, an Ex-FDA Official, Petitions the FDA to Immediately Stop LASIK & Investigate for Criminal Fraud

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Waxler Regulatory Consultancy LLC submits a 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 "PHA" with a voluntary recall of all LASIK devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for LASIK eye surgery.

Dean Andrew Kantis, Founder of http://www.LifeAfterLasik.com "Hurt LASIK Patient Network," is issuing the following press release based on the submission by Waxler Regulatory Consultancy, LLC, whom issued the FDA Petition today.

SUMMARY OF THE PETITION:
The "Citizen Petition" asks the FDA to immediately do the following:
•Seize all FDA approved lasers.
•Remove the FDA approval.
•Issue a Public Health Advisory "PHA."
•Investigate LASIK crimes as Criminal Crimes for confidential proof of fraud used in the clinical studies that were used to get LASIK FDA Approval.

PETITION CITED:
"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."

LASIK IS A PUBLIC THREAT:
"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."

MILLIONS OF EYES ARE PERMANENTLY DAMAGED FROM 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. LASIK NEVER MET THE 90% effectiveness when the true rate is approximately 57%."

CRIMINAL INVESTIGATION STARTED:
"CONFIDENTIAL information on these matters will be sent separately to FDA’s OFFICE OF CRIMINAL INVESTIGATIONS. Published scientific data shows LASIK devices induce an average adverse event rate of about 22% that persists beyond six months to five or more years. Moreover, the published data shows that LASIK devices transform healthy corneas into sick corneas that:"

  • Never completely heal
  • Are permanently weakened, vulnerable to trauma and inflammation
  • Cause neuropathic dry eyes
  • Have pathology that progresses annually
  • Are vulnerable to blinding corneal bulging (keratectasia)
  • Compromises night vision
  • Have unstable vision corrections that regress
  • Require eye care that otherwise would not be needed

32 PAGE FDA PETITION FILED CAN BE VIEWED HERE:
http://lifeafterlasik.com/LASIK%20Morris%20FDA%20Petition%20Jan%206%202011.pdf

The above mentioned Citizen Petition was filed by Dr. Morris Waxler, Waxler Regulatory Consultantcy LLC after having been sent to the FDA for immediate review, and then sent to Dean Andrew Kantis, founder of http://www.LifeAfterLasik.com for further news distribution.

This press release was released by:
Dean Andrew Kantis
Founder of http://www.LifeAfterLasik.com
"Hurt LASIK Patient Network"
754.234.9993

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