Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 01/05/2015 Notwithstanding a recent FDA-NIH-U.S. Navy collaborative study that downplayed LASIK vision-altering surgery risks, three activists petitioned FDA commissioner Margaret Hamburg 12/24/2014 to add a black box warning to the labeling of lasers approved for the procedure. The petition alleges a “high incidence of induced visual symptoms (double vision/ghosting, starbursts, glare, and halos) and dry eyes” and asks […]
FDA Dims LASIK Harms it Found in ‘Life Quality’ Study
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. October 20, 2014 In a long-awaited report on a collaborative study it conducted on the post-surgical quality of life of LASIK patients, FDA is downplaying the harms it found in up to 45% of 572 patients, adopting the industry-favored term “visual symptoms” vs. the agency’s former […]
LASIK Study Shows Significant Number of Problems
October 19, 2014 Preliminary results from FDA study of LASIK show significant number of patients experience problems. Presenting preliminary results of the long-awaited LASIK Quality of Life Study during a keynote lecture at a meeting of the American Academy of Ophthalmology in Chicago on 10/17/2014, ophthalmologist Malvina B. Eydelman, MD, director of the FDA’s Division […]
Give FDA Authority over All Medical Device Ads?
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 8/2/2014 Historically, U.S. law has given the Federal Trade Commission (FTC) primary authority to regulate the advertising and other promotion of prescription medical devices not otherwise “restricted” by FDA. Restriction most commonly occurs in the conditions of approval stipulated in writing by FDA at the time […]
Patient Advocate Slams FDA Denial of LASIK Petition
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 07/07/2014 LASIK patient advocate and former FDA LASIK advisory panel patient representative Paula Cofer has sharply criticized an eight-page FDA letter that denied a citizen petition submitted by former CDER branch chief Morris Waxler seeking the market withdrawal of approved LASIK excimer lasers and a public […]
How FDA Dropped Patient Warning Rule from LASIK Approvals
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 11/5/2013 FDA explains how a little-noticed change in its conditions of approval for LASIK lasers removed a patient-protection requirement two years before public complaints about eye injuries from the procedure erupted. Two years before rising complaints erupted in public from LASIK patients with post-surgical vision problems, […]
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 […]
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, […]