FDA Approves Laser to Correct Nearsightedness, Warns of Risks

The Food and Drug Administration approved the nation’s first laser to correct nearsightedness Friday but warned Americans to be cautious in deciding to get their eyes zapped because the device is risky.

“It is something new and it may be the right thing for some people, but it does not mean it’s right for everybody,” said the FDA’s medical device chief, Dr. Bruce Burlington.

The SVS Apex Excimer Laser System, manufactured by Summit Technology Inc. of Waltham, Mass., offers a 30-minute operation to help sharpen the vision of people who are nearsighted or unable to see clearly at a distance.

The approval means “the American public has access to the newest, very best technology available anywhere in the world,” said Harvard University’s Dr. Roger Steinert, who helped investigate Summit’s laser. “We now have validation . . . that laser vision correction is safe and effective.”

An estimated 70 million Americans are nearsighted, and laser advocates project 1.4 million may seek the treatment each year. It costs $1,500 to $2,000 per eye. Several generations of the laser have been widely available in Europe; the FDA approved the one now considered the gold standard.

Currently, Americans who hope to shed their glasses or contact lenses seek surgery called radial keratotomy, or RK. A surgeon uses a knife to make tiny cuts on the cornea, the clear tissue covering the iris and pupil. The cuts flatten misshapen corneas to bring vision closer to normal. About 250,000 Americans undergo it each year.

The laser operation, called photorefractive keratectomy, or PRK, uses a cold beam of ultraviolet light to flatten the cornea by vaporizing corneal cells. Some doctors say the laser is safer and more precise than RK.