Study Finds 21% of Serious Eye Injuries Due to LASIK

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 7/25/2013 Thirty-one months after it back-burnered a former CDRH [FDA’s Center for Devices and Radiological Health] branch chief’s petition seeking withdrawal of the LASIK indication for ophthalmic lasers based on unacceptably high permanent injury rates, CDRH has been sent a new retrospective study indicating that 21% […]

An Interview with Justice of Lasik Scandal

4/20/2013 A new website, LasikScandal.com, reveals risks and adverse effects of LASIK eye surgery, and exposes LASIK industry corruption. LasikNewswire’s editor interviewed the new site’s Director & Medical Researcher, Justice. LNW: Good evening, Justice, and thanks for giving us this interview. Tell us about yourself. How did you become interested in LASIK? Justice: I had […]

20/20 Institute Indianapolis Lasik slapped with FDA warning letter

From a 12/18/2012 FDA press release: The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, […]

Scott Hyver Visioncare slapped with FDA warning letter

From a 12/18/2012 FDA press release: The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, […]

Rand Eye Institute slapped with FDA warning letter

From a 12/18/2012 FDA press release: The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, […]

Eye Center of Texas slapped with FDA warning letter

January 14, 2013 From a 12/18/2012 FDA press release: The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information […]

Woolfson Eye Institute slapped with FDA warning letter

January 14, 2013 From a 12/18/2012 FDA press release: The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information […]

FDA ‘Has Moral Obligation’ to Intervene in Suicide

Reprinted with permission from www.fdaweb.com 7/25/2012 CDRH director Jeff Shuren was told 7/24 he has a “moral, if not a legal, obligation to follow up directly” with a patient who told his Center in a 6/6 MedWatch report that “I intend to end my life soon” because of LASIK-related eye injury. The plea came in […]

LasikPlus Vision Center, FDA warning letter 4/3/12

APR 3, 2012 WARNING LETTER VIA UNITED PARCEL SERVICE Ms. Casi Cleaveland Regional Director LasikPlus Vision Center 200 Galleria Parkway Suite 200 Atlanta, Georgia 30339 Dear Ms. Cleaveland: During an inspection of your firm located in Atlanta, Georgia, on October 5-6, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that […]

LASIK Founder Files NDA for LASIK Injury-healing Drug

Reprinted with permission from www.fdaweb.com 03/09/2012 David Muller, who as founder and CEO of Summit Technology gained in 1996 the first excimer laser approval for the controversial LASIK vision correction surgical procedure, announced 3/8 the submission of an NDA for VibeX (riboflavin ophthalmic solution)/KXL System to be used in treating corneal damage often associated with […]