THE TRUTH ABOUT LASIK

by CYNTHIA J. MACKAY, M.D., OPHTHALMOLOGIST Few ophthalmologists are willing to have LASIK done on their own eyes, but almost none will discourage his or her patients from having it done on their eyes. I am one of the very few ophthalmologists who is willing to speak out publicly against LASIK. Like most doctors, I am reluctant […]

Violative Medical Device Ads: Why FDA Doesn’t Act

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 01/04/2017 (Report by Jim Dickinson) FDA has statutory authority to regulate the advertising and promotion of “restricted” medical devices, but even in the face of injured patient complaints, it’s an authority it rarely uses. That’s probably because in the broad sweep of device safety issues and […]

Shuren Promises Action on Suicidal LASIK Patient

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 6/10/2016 Although CDRH has repeatedly refused in the face of mounting adverse reaction/injury reports to remove the LASIK indication from lasers labeled for that vision-enhancement indication, Center director Jeffrey Shuren 6/10 took less than 40 minutes to tell a LASIK activist CDRH would “look into” a […]

Hundreds Petition Congress to Fire CDRH’s Shuren

04-14-2016 Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. An Internet petition to Congress authored by LASIK injured patient/activist and former CDRH advisory committee consumer representative Paula Cofer has drawn more than 270 signatures from across the country in its first 24 hours, demanding the removal of CDRH director Jeffrey Shuren from office. Last […]

Despite Protests, FDA Hangs Tough on LASIK

9/9/2015 Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. Despite continued agitation on the part of patient activists claiming injuries from LASIK vision correction procedures, FDA said 9/9 it has “not found any new safety concerns associated with LASIK devices to lead it to believe that there is no longer a reasonable assurance that […]

1,073 LASIK Victims Ask FDA to Reconsider Petition Denial

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 05-08-2015 Attaching 1,073 signatures mostly from other purported victims of LASIK eye surgery, activist Paula Cofer 5/8 asked FDA acting commissioner Stephen Ostroff to reopen for consideration a petition from former CDRH ophthalmic device branch chief Morris Waxler that was denied last summer. The petition sought […]

FDA Panel to Consider Corneal Collagen Cross-linking

Tuesday, February 24, 2015 By Richard Smith           As with many regulatory proceedings, a Food and Drug Administration hearing today will have effects reaching far beyond its official topic. An FDA scientific advisory panel is gathering to consider a new treatment for keratoconus, a rare but potentially disabling eye disorder. How the FDA responds could […]

Device Maker Slammed by Injured Patients at FDA Meeting

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 2/24/2015 Avedro Inc. CEO David Muller was verbally battered by several injured LASIK patients during public presentations 2/24 at a joint meeting of two FDA advisory committees as he led his company’s efforts to win an approval recommendation for a new drug/device combination to treat eye disorders […]

Ex-FDAer Waxler to Oppose Avedro NDA at Advisory Cte.

By Jim Dickinson 02/18/2015 Former CDRH ophthalmic devices branch chief Morris Waxler will next week oppose an Avedro Inc. NDA seeking approval for riboflavin ophthalmic solutions with UVA irradiation for use in corneal collagen cross linking for the treatment of the conditions underlying progressive keratoconus or corneal ectasia following refractive surgery. The venue: the 2/24 […]

LASIK Activists Petition for Black Box Warning

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 […]