June 6, 2014 8:00 a.m. to 6:00 p.m.: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement .
June 6, 2014 8:00 a.m. to 6:00 p.m.: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.
Please click HERE for the current roster of the Ophthalmic Devices Panel.
During this meeting, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the KAMRA Inlay (Model ACI 7000) (KAMRA Inlay) submitted by applicant AcuFocus, Inc. The KAMRA Inlay is a permanent corneal implant that is placed intrastromally in a corneal pocket or under a corneal flap. The opaque annulus of the inlay reduces the aperture of the eye, which improves near vision by providing an increased depth of focus in the implanted eye. The proposed indication for use states that the KAMRA Inlay is indicated for the improvement of near and intermediate vision in presbyopic patients who require near or intermediate correction. The KAMRA Inlay is intended to be placed intrastromally in the cornea, on the visual axis, by way of a femtosecond laser-created pocket using a spot/line separation of 6×6 microns (µ) or less. The KAMRA Inlay should be placed at a depth equal to or greater than 180 µ.
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