Posted on 12/17/2009 Paula Cofer, FDA Patient Representative, served on the April 25, 2008 FDA Ophthalmic Devices Panel in Gaithersburg, MD. The meeting was called to discuss issues concerning post-market experiences with LASIK. Ms. Cofer expressed several concerns about the safety and long-term consequences of LASIK, and asked for changes to the labeling of excimer […]
The Truth Behind LASIK Satisfaction
12/13/2009 Patient satisfaction after LASIK, as measured by unvalidated surveys or questionnaires, is neither scientific nor a reliable indicator of LASIK safety or efficacy. LASIK surgeons report high patient satisfaction even in cases with poor night vision and sight-threatening complications. The “Hawthorne effect” 1 proposes that patients may rate their level of satisfaction with the […]
FDA Public Health Advisory Sought on LASIK Hazards
Reprinted with permission from fdaweb.com 11/06/2009 “The FDA’s mission is to serve and protect the public, not to serve industry,” says a 126-signatory letter to CDRH acting director Jeffrey M. Shuren, seeking a public health advisory on “the high incidence of adverse events and long-term consequences associated with LASIK surgery.” The five-page 11/2 letter, signed […]
List of FDA warning letters to LASIK clinics
Latest FDA Warning Letters 10/27/2009 Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking the link following each company name. Lasik Vision Institute Carmel, IN (10/9) Misbranded: FDA determined that the facility is a medical device user facility that is subject to the statutory reporting requirements of the Medical […]
FDA Issues Warning Letters to LASIK Facilities
For Immediate Release: Oct. 15, 2009 Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov Consumer Inquiries: 1-888-INFO-FDA FDA Announces Plans for LASIK Quality of Life Project Agency also Announces Warning Letters Issued to LASIK Facilities The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. […]
FDA Warning Letters Target MDR Reporting at LASIK Sites
Reprinted with permission from fdaweb.com 17 Warning Letters Target MDR Reporting at LASIK Sites 10/15/2009 FDA says it has issued Warning Letters to 17 LASIK ambulatory surgical centers after recent inspections revealed that they had inadequate systems for reporting adverse events related to the vision correction surgery. FDA has recently ramped up its enforcement efforts, […]
Group Asks for Recall of ‘All-laser LASIK’ Devices
Reprinted with permission from fdaweb.com 10/15/2009 LASIK Surgery Watch (LSW) says FDA should recall laser keratome devices used for LASIK flap recreation due to its negligence in clearing them without rigorous clinical trials. In a 10/10 letter to CDRH Office of Device Evaluation (ODE) director Donna-Bea Tillman, LSW cites a 10/14/08 letter from CDRH scientists […]
FDA’s Culture of Secrecy Will Beat Obama
Reprinted with permission from fdaweb.com 10/05/2009 [Analysis by Jim Dickinson*] Forget “open government,” especially at FDA. As the Obama administration visibly wilts under national security objections to a reporter’s shield law and resists a federal judge’s order that it release an FBI interview with former vice president Dick Cheney about who “outed” secret agent Valerie […]
NRC for Women & Families, FDA LASIK docket comment
Posted 9/26/2009 www.regulations.gov 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 […]