Military Deployments Delay FDA Studies on LASIK

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 9/9/2013 Post-operative quality-of-life studies on military personnel who have undergone LASIK eye surgeries have been delayed indefinitely due to personnel “deployments and the focus of all military staff on the war efforts,” an FDA spokeswoman tells FDA Webview. The study, known as Patient-Reported Outcomes with LASIK […]

The Scandal of LASIK

Copyright Perry Rosenthal, M.D. at www.bostoneyepain.org. Republished by permission. By Perry Rosenthal, M.D. 09-09-2013 Imagine a surgical procedure being performed for non-medical reasons on a healthy organ critical to our ability to function. Considering that this surgery neither treats nor prevents disease, what is its acceptable rate of serious and permanent complications? Shouldn’t it be […]

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 […]