BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALENS

    MDR report key: 1202447 · Received October 8, 2008

    Report

    Report Number
    2031924-2008-00289
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BAUSCH & LOMB SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P03002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE CRYSTALENS FELL APART AND WAS CUT IN HALF DURING HANDLING. NO PT CONTACT. ADD'L INFO HAS BEEN REQUESTED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL BAUSCH & LOMB SURGICAL HD500 014701

    Patients

    Seq Age Sex Outcome Treatment
    1