AcuFocus receives KFDA approval for KAMRA inlay to treat presbyopia

Published on May 2, 2012 at 12:19 AM · 1 Comment

AcuFocus is pleased to announce they received approval from the Korean Food and Drug Administration (KFDA) for the KAMRA™ inlay, making this revolutionary treatment option for near vision loss available to the Korean population. The majority of people experience loss of near vision, or presbyopia, as they age. The KAMRA corneal inlay is designed to only permit focused light rays to enter the eye, allowing patients to see near and intermediate objects more clearly without glasses. Patients who have undergone this procedure are once again seeing details such as mobile devices, labels, and time on a wristwatch with ease.    

As a novel technology, the KAMRA inlay went through a very rigorous approval process. The KFDA required extensive data on clinical results, safety, device design and biocompatibility. "We are extremely thrilled to be able to offer this advanced vision correction technology in Korea," said Ed Peterson, AcuFocus President and Chief Executive Officer. "The approval from the KFDA is a testament to the excellent global results achieved with the device."

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Comments
  1. Cesar Salinas-La Rosa Cesar Salinas-La Rosa Australia says:

    I am pathologist from Melbourne Australia.
    I have noted in two cases that there was presence of multinucleated Giant cells attached to the extracted inlay.
    Regards
    Cesar

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