FDA studies lasik-surgery complaints


Surgeons say 95 percent of people are satisifed.

WASHINGTON (AP) — A decade after it first approved devices for laser eye-correcting surgery, the Food and Drug Administration is taking a closer look at grievances from patients, including blurred vision and dry eyes.

An estimated 6 million Americans have undergone Lasik surgery, which permanently reshapes the cornea, a clear layer covering the eye. There are no guarantees of 20/20 vision and the long-term safety of the procedure is still unknown.

But the society of eye surgeons who perform Lasik says 95 percent of patients are satisfied with their results. The group is expected to tell regulators later this week that most side effects from Lasik surgery are rare and temporary.

FDA will hear from Lasik eye surgeons as well as disgruntled patients at a meeting Friday of its outside panel of eye experts.

The agency will ask the expert panel whether educational materials given to patients considering Lasik need to be changed or updated, according to documents posted to the agency’s Web site Wednesday.

Regulators agreed to hold the meeting after years of complaints from a small group of patients who say their eyesight has been irreparably damaged by the surgery. The agency received 140 reports of Lasik-related problems between 1998 and 2006, according to an agency spokeswoman.

Dean Kantis, who is scheduled to speak Friday, says his vision has suffered since his Lasik surgery in 1998.

“My life is a blur,” Kantis said. “When I look at a computer screen I see two pages; when I look up at the moon, I see three of them.”