FDA Warns LASIK Providers: Stop Making False Claims

On 9/23/2011, the FDA issued a Letter to Eye Care Professionals. From the HealthDay article: In its latest salvo against deceptive, potentially harmful advertising, the FDA is now giving eye doctors 90 days to get in line and update any advertising or promotional materials that make false claims. After this time, the agency will take regulatory action, said FDA spokeswoman Erica Jefferson.

On 1/6/2011, the former head of the FDA branch responsible for reviewing LASIK clinical trials filed a petition with the FDA calling for immediate withdrawal of approval for LASIK. Read the petition and show your support. Sign petition

CNN 9/22/2010: LASIK safety questioned.

9/14/2010: Lasik Surgeons Resort to Trademark Law to Suppress Criticisms. Read article

7/7/2010: State launches investigation into Lasik eye surgeon, Paul Cutarelli. Read article

7/29/2011: FDA urged to revamp its 510(k) process for clearing medical devices, which includes all-laser bladeless IntraLase lasers. Read article Read what LASIK patient advocates are saying about this: Link

5/10/2010: Former FDA chief of ophthalmic devices warns that LASIK risks outweigh benefits. Read letter

4/19/2010: editor criticizes FDA regulation of LASIK devices and its relationship with the American Society of Cataract and Refractive Surgery (ASCRS), and criticizes FDA’s decision to collaborate with Department of Defense (Navy) in LASIK study. Read letter

3/18/2010: Federal lawsuit targets TLC LASIK Centers for poor screening, seeks class action status – Business Week. Read article

ABC Good Morning America 2/25/2010: Former FDA regulator says LASIK side effects weren’t taken seriously enough.

1/13/2010: Docs seek to stifle patients’ rants on Web sites – Read article

1/11/2010: For Some, Lasik Brings More Problems Than Solutions – National Public Radio. Read/listen

11/16/2009: LASIK surgeon jailed in a murder-for-hire scheme – The Seattle Times. Read article

11/6/2009: FDA Public Health Advisory Sought on LASIK Hazards. Read article

10/20/2009: FDA issued warning letters to LASIK clinics after inspections revealed inadequate systems for reporting unexpected side effects (adverse events). Link to FDA Consumer Update

Editor’s note: We recommend that Dr. Stephen Updegraff of Updegraff Vision take steps to ensure that his surgery center has procedures in place to report bad outcomes from LASIK, such as chronic dry eyes and night vision problems, to comply with federal law.

10/16/2009: Complaints by Unhappy Lasik Patients Spurred FDA Warning, Study – Read article

10/15/2009: Group Asks for Recall of ‘All-laser LASIK’ Devices. Read article

9/30/2009: Prominent Florida eye doctor charged with fraud – Read article

9/27/2009 Tampa Tribune: Surgical mistakes, eye docs among worst. Read article

9/14/2009: LASIK Surgery Watch Calls on FDA-CDRH Acting Director, Jeffrey Shuren, to Withdraw Approval of Lasers Used to Perform LASIK. Read article

9/8/2009: Former FDA Official Says FDA “Screwed Up” In Approving LASIK. Read article

9/5/2009 LASIK surgery does not necessarily mean the end to glasses. Read article

6/17/2009: LASIK surgeon charged with fraud, kills himself and wife – Read article

6/11/2009: $5.6 Million LASIK Medical Malpractice Verdict: Read press release

3/13/2008: LASIK Surgery, When the Fine Print Applies to You – The New York Times. Read article

3/13/2007: LASIK surgeon jailed in Florida – St. Petersburg Times. Read article