LASIK Complaint on Violative Ads Seeks Woodcock Action

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished with permission. 03/31/2021 The leader of a Facebook group involving patients injured by LASIK eye correction procedures is urging FDA acting commissioner Janet Woodcock to crack down on false and misleading advertising by LASIK providers. Paula Cofer, who founded the 7,400-member LASIK Complications Facebook Group in 2014 to […]

Modern laser in situ keratomileusis outcomes – A review.

The LASIK industry has a long history of manipulating data and publishing junk science to protect the public perception of LASIK. In 2009, leading LASIK surgeons published a literature review titled LASIK world literature review: quality of life and patient satisfaction1 which concluded that “95.4% of patients were satisfied with their outcome after LASIK surgery“. […]

FDA Lifts, Then Dashes LASIK Patients’ Hopes

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished with permission. After a decade of stonewalling injured patients’ complaints about adverse reactions to LASIK vision-therapy laser surgeries, CDRH last week lifted their hopes for a change of heart at a one-hour meeting — then dashed them five days later in a 9/18 statement that doubled down on […]

FDA Meets with Patients Advocating LASIK Ban

NEWS RELEASE September 7, 2018 Contact: Morris Waxler, PhD, 608-219-7947, morriswaxler@gmail.com Mark your calendar for a news conference with a group advocating a ban on LASIK eye surgery. The news conference will take place on September 13, 2018 from 1:00 to 2:00 PM, in the Maple Room at the Sheraton Hotel, 8777 Georgia Ave., Silver […]

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 […]