MARYLAND : FDA Warns Against Unapproved Lasers

Federal regulators in Gaithersburg, Md., issued an unusually strong warning to stop eye doctors from using unapproved laser surgery machines to correct nearsightedness. The warning is the latest in a blitz of controversy over a popular laser surgery that promises better vision without glasses to many of the 60 million Americans who are nearsighted. The FDA has approved two lasers since last fall, made by Summit Technology and Visx, to help people see more clearly at a distance. But some doctors are importing cheaper, used lasers from Europe, where they have been sold for several years, or building their own, meaning some patients are undergoing surgery on machines not FDA-approved as safe. The agency could seize an unapproved machine or go to court to stop its use.