BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPT

    MDR report key: 2900966 · Received January 3, 2013

    Report

    Report Number
    1119279-2013-00007
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 4, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD WAS REVIEWED AND THERE WERE NO NONCONFORMITIES OR ANOMALIES RELATED TO THIS COMPLAINT. THE PRODUCT WAS DEEMED ACCEPTABLE FOR RELEASE. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS EXPLANTED DUE TO CIRCULAR MARKS ON THE OPTIC SURFACE OF THE LENS THAT REDUCED THE PT'S VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372 AKREOS ADAPT HQL; INTRAOCULAR LENS HQL BAUSCH + LOMB ADAPTAOP 1117822069

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other