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, 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 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 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 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 […]