NRC for Women & Families, FDA LASIK docket comment

Posted 9/26/2009 Document ID: FDA-2008-N-0488-0024 September 14, 2009 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Comments of the National Research Center for Women & Families on “Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket” [Docket No. FDA-2009-N-0488] The National […]

Robert Selkin, MD Connected to LASIK Suicide

Posted 9/22/2009 FDA Hearing – April 25, 2008 Presentation of Todd Krouner, Esq. MR. KROUNER: Good morning again. I am here on behalf of Amanda Campbell. My name is Todd Krouner. I was recently retained by her. She is a widow now in Brentwood, Tennessee, whose husband, Lawrence Campbell, a police officer with that police […]

Jeffrey Shuren Called on to Withdraw FDA Approval of LASIK Devices

FDA Lasik Response to FDA Webview Challenged Reprinted with permission from 09/14/2009 LASIK Surgery Watch says it disputes most of FDA’s response to FDA Webview in our publication of an interview with former FDA Division of Ophthalmic Devices Diagnostic and Surgical Devices Branch chief Morris Waxler, who said that FDA was mistaken in approving […]

FDA to Investigate Deceptive, Misleading LASIK Ads

Reprinted with permission from CDRH to Review 18 ‘Violative’ LASIK Ads 09/11/2009 Responding to a complaint by Florida-based LASIK activist Dean Andrew Kantis, CDRH’s Office of Compliance said 9/11 it would give “appropriate review” to 18 Web site advertisements by LASIK surgery firms that Kantis had gathered and sent to office director Timothy A. […]

Former FDA Official Says FDA “Screwed Up” In Approving LASIK

Former branch chief for diagnostic and surgical devices alleges the FDA caved under pressure from ophthalmologists to approve LASIK devices, despite high incidence of complications. Reprinted with permission from On LASIK ‘We Screwed Up’ Says Ex-CDRH Review Leader 09/08/2009 When it first approved laser devices for LASIK indications in 1998, CDRH “screwed up” in […]