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., 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 (laser) 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.
The laser operation uses a cold beam of ultraviolet light to flatten the cornea by vaporizing corneal cells.