BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADVANCE ASPHERIC LENS

    MDR report key: 2010739 · Received March 2, 2011

    Report

    Report Number
    1119279-2011-00053
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    December 21, 2009
    Report Date
    February 1, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PROGRESSIVE OPACIFICATION OF AN AKREOS ADAPT AO LENS APPROX THREE YEARS AFTER CATARACT SURGERY AND LENS IMPLANTATION IN THE PATIENT'S LEFT EYE. THE PATIENT'S VISUAL ACUITY AS OF (B)(6) 2011 WAS 20/125. THE IOL EXCHANGE WAS SCHEDULED FOR (B)(6)2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADVANCE ASPHERIC LENS INTRAOCULAR LENS HQL BAUSCH + LOMB ADAPT-AOT 1607213

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R