FDA Approves Monovision LASIK

WASHINGTON, July 2007

The U.S. Food and Drug Administration has announced approval of a common corrective eye surgery technique, known as monovision LASIK, in which one eye is corrected for near vision and the other eye is corrected for distance.

The LASIK procedure often is used off label for correcting presbyopia, the age-related inability to focus at all distances. But the recent FDA action for the first time officially approves use of the monovision technique with a specific excimer laser, the Advanced Medical Optics (AMO) and Visx CustomVue.

As follow-up, FDA officials say they also have asked AMO and Visx to conduct a six-month study evaluating visual outcomes and quality-of-life issues for 500 individuals who have undergone monovision LASIK.