BEUDAMED
    FDA Enforcement Class II Terminated

    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.

    Recall: Z-1235-2016 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1235-2016
    Event ID
    73343
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AcuFocus, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 30, 2016
    Initiation Date
    February 11, 2016
    Classification Date
    March 24, 2016
    Termination Date
    May 4, 2016
    Address
    32 Discovery Ste 200, N/A, Irvine, CA, 92618-3161, United States

    Description

    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.

    Reason

    AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.

    Code Info

    Lots A534-1014 and A535-1014

    Distribution

    International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.

    Quantity

    182 units