BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSTERIOR CHAMBER INTRAOCULAR LENS

    MDR report key: 1052479 · Received May 22, 2008

    Report

    Report Number
    1920664-2008-00583
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P840039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE LENS WAS RECEIVED INCORRECTLY PLACED IN CARRIER. PARTICULATE AND DRIED SALINE SOLUTION ARE VISIBLE ON THE LENS OPTIC. ONE HAPTIC OF THE LENS IS MISSING. DUE TO THE CONDITION IN WHICH THE LENS WAS RECEIVED, WE CANNOT DETERMINE THE CAUSE OF THIS MALFUNCTION.

    Description of Event or Problem · 1

    THE HAPTIC OF THE LENS WAS FOUND BROKEN UPON OPENING THE LENS CARRIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSTERIOR CHAMBER INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1