WASHINGTON — 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.
The 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 Wednesday to the agency's Web site (www.fda.gov).
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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."
Double vision, night-vision disturbances and dry eye are among the side effects outlined in literature given to Lasik patients, but Kantis and others say physicians often gloss over the risks.
An FDA spokeswoman pointed out the agency has no authority over how physicians handle patients. Regulators have agreed to work with the American Society of Cataract and Refractive Surgery on a large-scale study of patients' quality of life after surgery.
