April 24 (Bloomberg) -- Complaints about Lasik eye surgery using lasers made by companies including Advanced Medical Optics Inc. and Alcon Inc. are a priority for U.S. regulators, a government official said today.

The Food and Drug Administration, working with doctors' groups and the National Eye Institute, plans to study how Lasik affects patients' quality of life no later than next year, Daniel Schultz, head of the agency's medical devices center, said today. Identifying why complications occur will help those considering Lasik make more educated choices, he said.

More than 12 million people in the U.S. have had Lasik to improve their vision since the procedure was approved in 1995, and 5 percent say they aren't satisfied with the results, according to the American Society of Cataract and Refractive Surgery. Complications after surgery can include dry eye, blurriness and even loss of vision. The FDA got 140 reports of side effects with Lasik from 1998 to 2006.

``Clearly there is a group that aren't satisfied and don't get the results that they expect,'' Schultz told reporters on a conference call. Studying these patients ``is very, very high on the agency's priority list.''

Advanced Medical, of Santa Ana, California, fell 11 cents to $20.05 in New York Stock Exchange composite trading at 4:15 p.m. Alcon, the Hunenberg, Switzerland-based company selling a majority stake to Novartis AG, gained $1.62, or 1.1 percent, to $154.99.

Paper-Thin Flap

Lasik surgeons slice a paper-thin hinged 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, making it steeper corrects farsightedness and smoothing out irregularities repairs astigmatism, or blurry vision. Lasik stands for laser-assisted in situ keratomileusis.

Permanent vision correction has become increasingly popular as new technologies eliminate the need for glasses and contact lenses. Some unhappy patients have urged the FDA in citizen petitions to rescind approval of lasers linked to side effects and phase out older devices as new technology is introduced.

People who say they've had unsuccessful surgery air their complaints on Web sites such as lasikcomplications.com, which lists the ``Top 10 Reasons Not to Have Lasik surgery.''

A Wax Paper View

Barbara Berney, 54, of Rockford, Illinois said she often feels as if she is viewing the world through wax paper since undergoing Lasik surgery in 2001. She had the surgery because she was no longer able to read and her doctor said Lasik would solve that, she said.

Instead, her vision constantly changes, she can't see in some lighting conditions and can no longer drive at night and her eyes are dry, said Berney, a graphic designer who composes digital art on a computer.

``You only get one pair of eyes,'' she said in a telephone interview. ``And once they're gone, you're done. There is no getting them back. You can't undo this.''

Berney is the president of the Vision Surgery Rehab Network, a non-profit dedicated to patient advocacy and rehabilitation of vision surgery complications.

The FDA asked the American Academy of Ophthalmology, the government-funded Eye Institute and the cataract surgery society in July to review published data on Lasik surgery and make a recommendation as to whether additional research was needed to examine patients' quality of life.

A joint task force, formed of representatives from the four groups, reported in March that its analysis of 19 studies in the past 10 years found a 95 percent satisfaction rate among 2,199 patients worldwide.

TLC Vision, LCA-Vision

Device makers and operators of Lasik surgery centers including TLC Vision Corp., of Mississauga, Ontario, and LCA- Vision Inc., of Cincinnati, insist the procedures are safe.

An FDA advisory panel will discuss the planned study at a public hearing tomorrow in Gaithersburg, Maryland.

``There is no surgical procedure or contact lens that you can wear or aspirin tablet that you can take that doesn't entail some risk,'' said Roy Rubinfeld, an ophthalmologist in Chevy Chase, Maryland, who has performed more than 20,000 Lasik surgeries, in a phone interview. ``I hope that this hearing will validate what has been my personal experience, that Lasik is perhaps one of the greatest surgical procedures.''

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

Last Updated: April 24, 2008 17:04 EDT