LASIK Activists Seek Hill Hearings on FDA Inaction

Reprinted with permission from 03/30/2010 The organizers of two Internet-based LASIK patients’ protest groups wrote 14 Capitol Hill lawmakers 3/29 asking for a hearing on FDA’s “egregious” approval of the laser devices used in this booming eye-surgery retail industry. Stressing the elective, cosmetic nature of the procedure, Fort Lauderdale, FL-based Dean Kantis and Paula […]

TLC LASIK Centers hit with class action lawsuit

Reprinted with permission from As FDA Awaits LASIK Study, Lawsuit Hits Big Player 03/18/2010 As FDA continues to await the results of a nationwide collaborative study on after-effects of LASIK eye surgery, due in 2012, injured patients have begun filing lawsuits based on their discontent with those after-effects — chronic and painful dry eyes, […]

EX-FDAer Waxler Says LASIK Effects Not Taken Seriously

Reprinted with permission from 2/25/2010 In his first television interview on the subject, former CDRH branch chief for diagnostic and surgical devices Morris Waxler says that the agency didn’t pay enough attention to negative side effects in some patients. Speaking in an exclusive on ABC’s Good Morning America, Waxler said the staff didn’t know […]

Paula Cofer, Patient Rep, presents concerns about LASIK to the FDA

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 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 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 […]