GAITHERSBURG, Maryland — The ophthalmic devices advisory committee voted 12-0 that the benefits of the Acrysof IQ ReSTOR intraocular lens made by Alcon (Fort Worth, Texas), outweigh the risks, thus bringing an end to another case of device lag. The device earned a CE mark in 2010 and is available in Canada, a fact which one panel member indicated was part of his motive for voting in support of the device. As is commonly noted, FDA does not necessarily adopt the position voiced by an advisory committee, but the overwhelming affirmative vote and the device's widespread availability outside the U.S. suggests the agency will green-light the device. Read More
