March 20, 2013
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AcuFocus submits premarket approval application for corneal inlay
AcuFocus has completed submission of its premarket approval application to the U.S. Food and Drug Administration for the Kamra corneal inlay, according to a news release.
The device has a 1.6-mm aperture to allow only focused light to enter the eye, improving near and intermediate vision without reducing distance vision, the release said.
The inlay is approved in 47 countries and has been implanted almost 20,000 times. It is the first corneal inlay for presbyopia treatment submitted to the FDA.