BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1063245 · Received June 19, 2008

    Report

    Report Number
    1920664-2008-00663
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE LENS WAS EVALUATED AND ONE OF THE HAPTICS WAS FOUND BENT. THE CAUSE OF THE DAMAGE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING THE INSERTION OF THE LENS, A HOLE WAS TORN IN THE LENS CAPSULE. THE INCISION WAS ENLARGED TO REMOVE AND REPLACE THE LENS.

    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 Required Intervention