FDA Outlines ‘Secret’ LASIK Study Details

Reprinted with permission from www.fdaweb.com 10/19/2010 A year after announcing a study to determine the percentage of LASIK laser vision-correction patients with significant quality of life problems after having the surgery and to identify predictors of these problems, FDA 10/19 provided an update on its plans for the three-part study that will run until the […]

x-FDAer Waxler, Eye Surgeon Spar on CNN Over LASIK

Reprinted with permission from www.fdaweb.com 9/28/2010 Former CDRH chief of ophthalmic devices Morris Waxler and leading Houston, TX ophthalmic surgeon Stephen G. Slade came to a televised Mexican stand-off 9/28 on the safety and effectiveness of elective LASIK vision correction. After the seven-minute CNN segment, anti-LASIK activists accused Slade of making false statements in it. […]

FDA Issues Additional Warning Letters to LASIK Clinics

8/16/2010 The Food and Drug Administration has slapped several more LASIK facilities with warning letters for violations of the medical device reporting (MDR) regulations. Federal law requires surgical facilities to track and report adverse events related to FDA-regulated medical devices such as those used to perform LASIK. Critics of the LASIK procedure have long accused […]

FDA Lacks Transparency in LASIK Investigation

Reprinted with permission from www.fdaweb.com 05/25/2010 Oil Spill Has a Lesson for FDA: Federal Impotence [Analysis by Jim Dickinson*] Some sides see it as that old Washington blame game — the Gulf of Mexico oil spill is “Obama’s Katrina.” That may be so, but nevertheless, there is a sobering message for FDA in this disaster. […]

Former FDA LASIK Chief Calls Clinical Trial ‘Unethical’

Reprinted with permission from www.fdaweb.com 05/07/2010 Former CDRH chief of ophthalmic devices Morris Waxler, who was in charge of evaluation LASIK devices approved between 1996 and 2000, told the American Society of Cataract and Refractive Surgeons (ASCRS) 5/7 its proposed Phase 2 keratectasia trial on LASIK effects is unethical and “I will do everything I […]

LASIK Activists Seek Hill Hearings on FDA Inaction

Reprinted with permission from www.fdaweb.com 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 www.fdaweb.com 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 www.fdaweb.com 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 […]

Dr. Quentin Franklin and LasikPlus Sued for LASIK Malpractice

02-14-2010 PRESS RELEASE – FOR IMMEDIATE RELEASE Laurie Shrieves v. Quentin Franklin, M.D., and LCA-Vision, Inc. d/b/a LASIKPlusVirginia Circuit Court for the City of Chesapeake Case No. CL 10000278-00 DR. QUENTIN FRANKLIN AND LASIKPLUS SUED FOR LASIK MALPRACTICE – On February 5, 2010, plaintiff, Laurie Shrieves, filed suit against Quentin Franklin, M.D., and LCA-Vision, Inc., […]