FDA to review Lasik eye surgery
The potential benefits and hazards of Lasik eye surgery will be brought into sharp focus on Friday when the U.S. Food and Drug Administration meets with patients and surgeons in Maryland.
The FDA panel will assess if educational materials provided to patients should be revised and updated, the agency said on its website.
The Lasik (Laser-Assisted in Situ Keratomileusis) procedure employs laser beams to reshape the cornea to improve near-sightedness, far-sightedness and astigmatism. An estimated 1.4 million surgeries were performed in North America in 2007, according to Lasik MD — a provider of laser eye correction.
Risks of the procedure include loss of vision, dry eye syndrome and poor night vision. But according to the American Society of Cataract and Refractive Surgery, surgeries are not successful in two to three per cent of cases.
Dean Kantis, who will address the FDA panel on Friday, said since his surgery in 1998, he has struggled with poor vision.
"My life is a blur," Kantis told the Associated Press. "When I look at a computer screen, I see two pages; when I look up at the moon, I see three of them."
Kantis said he failed to fully understand the risks associated with the eye-correcting surgery.
"Just before the procedure, they shove the informed consent form in front of you, but you just sign it and no one reads the fine print," he said.
A U.S. FDA spokeswoman said that between 1998 and 2006, 140 reports of problems linked with the laser procedure have been filed with the FDA.