Reprinted with permission from fdaweb.com 06/03/2009 In a battery of new letters to FDA and its Capitol Hill overseers, protesters who say they have been permanently damaged by LASIK vision-correction surgery escalated their campaign this week to have the agency upgrade patient disclosures and warnings in the labeling of devices used and initiate inspections at […]
Citizen Petition to Inspect LASIK Clinics Filed With FDA
Posted 5/26/2009 Petitioner calls for inspection of LASIK clinics, sanctions for clinics that fail to report complications. May 25, 2009 Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Dr. Margaret A. Hamburg Commissioner of U.S. Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 Dr. Joshua […]
FDA Petitioned to Inspect and Sanction LASIK Facilities on MDRs
Reprinted with permission from fdaweb.com 5/26/2009 Days after FDA principal deputy commissioner Joshua Sharfstein launched an investigation into mounting complaints by injured LASIK vision-correction patients, one of them 5/25 filed a citizen’s petition asking for sanctions against LASIK clinics that have not reported adverse events as required under the medical device reporting (MDR) regulation. The […]
FDA Acting Commissioner Investigates LASIK Complaints
Reprinted with permission from fdaweb.com Sharfstein Investigates LASIK Patients’ Complaints 05/21/2009 FDA acting commissioner Joshua Sharfstein told FDA Webview 5/21 that he is looking into complaints of many LASIK (laser-assisted in situ keratomileusis) eye vision enhancement surgery patients that the agency has failed to honor its commitments to investigate their complaints since 2006 that the […]
Letter to Congress Seeking Moratorium on LASIK Devices
Posted 5/21/2009 The following letter was sent to members of the U.S. House of Representatives Committee on Energy and Commerce and Subcommittee on Oversight and Investigations and others members of Congress. May 8, 2009 The Honorable Henry Waxman Chairman Committee on Energy and Commerce 2125 Rayburn House Office Building Washington, DC 20515-6115 Dear Chairman […]
Bladeless LASIK device cleared by FDA without clinical trials
FDA Webview (reprinted with permission) 5/15/2009 510(k) Route to Market Under New Attack Two new pointers to the inadequacy of Sec. 510(k) to protect public health and safety emerged last week in a New York Times exposé of vaginal sling toxicity and new medical literature reporting elevated safety issues with new ophthalmic lasers. Both devices, […]
FDA Update on LASIK
4/30/2009 Question: What has the FDA accomplished in the past year to protect the public from being harmed by LASIK? Answer: Not much. March 27, 2009 (Gaithersburg, Maryland). Good morning. I’m Kwame Ulmer, Chief of the Diagnostic and Surgical Devices Branch, and this morning I’ll be giving an update on activities in our branch. On […]
Ophthalmologist Warns the FDA, LASIK is Russian Roulette
8/9/2008 This letter addresses my concern about the safety of LASIK surgery. I have practiced ophthalmology for thirty-three years. After taking all the courses on LASIK, I decided not to do the surgery. I believe LASIK surgery is not consistent with the ophthalmologist’s hypocritic oath of “first do no harm. ” Statistics on complications could […]
Did the FDA and ASCRS knowingly misrepresent the numbers of bad LASIK outcomes?
6/16/2008 Reports of LASIK complications to the FDA’s MedWatch program (MAUDE Database) for medical device adverse events have nearly doubled since the public announcement of the the April 25th, 2008 Special Hearing of the Ophthalmic Devices Panel, held to discuss post-LASIK quality of life, depression, and suicide. At the hearing, two medical doctors, two optometrists, […]
LASIK Industry Deceives the Public with Smoke and Mirrors
5/31/2008 Amid bad publicity for the LASIK industry, a group of LASIK surgeons announced ‘preliminary’ findings from an ‘unpublished’ review of medical studies showing a “95.4% global LASIK satisfaction rate”. Press releases issued by LASIK industry insiders appeared to link this literature review to the FDA with misleading statements such as, “The FDA reaffirms that […]