Complaints By Unhappy Lasik Patients Spurred Fda Warning, Study
The Food and Drug Administration said yesterday that recent inspections showed 17 undisclosed Lasik centers had inadequate systems for reporting adverse effects of the surgery. The agency also said it began a long-planned study with the National Eye Institute and the Department of Defense to examine how the laser procedures affect patients quality of life.
More than 12 million people in the U.S. have had Lasik to improve their vision since the procedure was approved in 1995. The American Society of Cataract and Refractive Surgery estimates up to 5 percent of patients arent happy with their results. Some dissatisfied consumers say those numbers are low and have set up Web sites to publicize their complaints.
“There has been a lot of pressure from unhappy patients to do something,” said Barbara Berney, a patient who had a failed Lasik surgery in 2001 and now cant drive at night or see in rooms with fluorescent light. She likens her vision to “looking through wrinkled wax paper.”
Berney is president of the Vision Surgery Rehab Network, which helps patients find other doctors to repair flawed procedures. She also is a patient representative to the FDA panel that will help conduct the quality-of-life study. That study was first announced after an agency hearing in April 2008 where many patients testified about negative Lasik experiences.
Delay Disappointing
“Im disappointed that it hadnt started sooner,” Berney said yesterday in a telephone interview.
Lasik surgeons slice a paper-thin flap from the top of the cornea covering the front of the eye and then reshape it, taking about 10 to 15 minutes per eye. Flattening the cornea fixes nearsightedness while making it steeper corrects farsightedness. Smoothing out irregularities repairs astigmatism, which causes blurry vision. Lasik stands for laser-assisted in situ keratomileusis.
Risks associated with Lasik treatment include partial loss of vision, double vision and dry eye syndrome, according to the FDA Web site.
Operators of Lasik surgery centers include TLC Vision Corp., based in Mississauga, Ontario, and LCA-Vision Inc. of Cincinnati. Advanced Medical Optics, a unit of Abbott Laboratories in Abbott Park, Illinois, and Alcon Inc., a unit of Swiss company Nestle SA, are among companies that make lasers used in the surgery.
FDA Inspections
Six TLC Vision centers were visited by FDA inspectors and four received warning letters, said James B. Tiffany, the companys president and chief operating officer.
James Salz, an ophthalmologist and clinical professor at the University of Southern California who owns a Los Angeles vision surgery center with other doctors, said Lasik is safe and effective for the vast majority of patients though it carries risks like any medical procedure.
The most frequent complication is infection while equipment-related problems are rare, he said.
“This is probably one of the most common elective procedures ever,” he said yesterday in a telephone interview. Until the economy declined last year, the industry was “doing over a million surgeries a year.”
Dissatisfied activists who have started Web sites are a small fraction of laser eye surgery patients, he said.
Pretty Successful
“Several hundred unhappy people out of millions means its a pretty successful procedure,” he said.
The FDA is continuing its inspections of Lasik operators, said Jeffrey Shuren, acting director of the agencys Center for Devices and Radiological Health.
Complaints By Unhappy Lasik Patients Spurred Fda Warning, Study
The Food and Drug Administration said yesterday that recent inspections showed 17 undisclosed Lasik centers had inadequate systems for reporting adverse effects of the surgery. The agency also said it began a long-planned study with the National Eye Institute and the Department of Defense to examine how the laser procedures affect patients quality of life.
More than 12 million people in the U.S. have had Lasik to improve their vision since the procedure was approved in 1995. The American Society of Cataract and Refractive Surgery estimates up to 5 percent of patients arent happy with their results. Some dissatisfied consumers say those numbers are low and have set up Web sites to publicize their complaints.
“There has been a lot of pressure from unhappy patients to do something,” said Barbara Berney, a patient who had a failed Lasik surgery in 2001 and now cant drive at night or see in rooms with fluorescent light. She likens her vision to “looking through wrinkled wax paper.”
Berney is president of the Vision Surgery Rehab Network, which helps patients find other doctors to repair flawed procedures. She also is a patient representative to the FDA panel that will help conduct the quality-of-life study. That study was first announced after an agency hearing in April 2008 where many patients testified about negative Lasik experiences.
Delay Disappointing
“Im disappointed that it hadnt started sooner,” Berney said yesterday in a telephone interview.
Lasik surgeons slice a paper-thin flap from the top of the cornea covering the front of the eye and then reshape it, taking about 10 to 15 minutes per eye. Flattening the cornea fixes nearsightedness while making it steeper corrects farsightedness. Smoothing out irregularities repairs astigmatism, which causes blurry vision. Lasik stands for laser-assisted in situ keratomileusis.
Risks associated with Lasik treatment include partial loss of vision, double vision and dry eye syndrome, according to the FDA Web site.
Operators of Lasik surgery centers include TLC Vision Corp., based in Mississauga, Ontario, and LCA-Vision Inc. of Cincinnati. Advanced Medical Optics, a unit of Abbott Laboratories in Abbott Park, Illinois, and Alcon Inc., a unit of Swiss company Nestle SA, are among companies that make lasers used in the surgery.
FDA Inspections
Six TLC Vision centers were visited by FDA inspectors and four received warning letters, said James B. Tiffany, the companys president and chief operating officer.
James Salz, an ophthalmologist and clinical professor at the University of Southern California who owns a Los Angeles vision surgery center with other doctors, said Lasik is safe and effective for the vast majority of patients though it carries risks like any medical procedure.
The most frequent complication is infection while equipment-related problems are rare, he said.
“This is probably one of the most common elective procedures ever,” he said yesterday in a telephone interview. Until the economy declined last year, the industry was “doing over a million surgeries a year.”
Dissatisfied activists who have started Web sites are a small fraction of laser eye surgery patients, he said.
Pretty Successful
“Several hundred unhappy people out of millions means its a pretty successful procedure,” he said.
The FDA is continuing its inspections of Lasik operators, said Jeffrey Shuren, acting director of the agencys Center for Devices and Radiological Health.