BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1000954 · Received February 20, 2008

    Report

    Report Number
    1920664-2008-00233
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MDR 1920664-2008-00234 FOR DELIVERY DEVICE USED WITH THIS THE INTRAOCULAR LENS.

    Description of Event or Problem · 1

    THE DOCTOR FOUND ONE OF THE HAPTICS BENT AFTER THE LENS WAS IMPLANTED IN THE PT'S EYE. THE LENS WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC LENS INTRAOCULAR LENS HQL BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention