BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1181229 · Received September 29, 2008

    Report

    Report Number
    2031924-2008-00299
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    May 21, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BAUSCH & LOMB SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS IMPLANTING THE CRYSTALENS AND POSTOPERATIVELY, HE WAS NOT SATISFIED WITH THE RESULTS. A YAG PROCEDURE WAS PERFORMED AND THE LENS WAS SUBSEQUENTLY EXCHANGED FOR A DIFFERENT LENS MODEL. THIS REPORT IS BEING FILED ON THE BASIS OF UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL BAUSCH & LOMB SURGICAL AT50SE 012000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention