BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1243693 · Received November 25, 2008

    Report

    Report Number
    2031924-2008-00320
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 28, 2008
    Manufacturer
    BAUSCH & LOMB SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    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 PHYSICIAN REPORTS THAT THE CRYSTALENS TORE DURING INSERTION USING THE B&L LENS INJECTOR SYS. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE ORIGINAL INCISION AND REMOVE AND REPLACE THE LENS INTRAOPERATIVELY. THE BACKUP CRYSTALENS WAS IMPLANTED SUCCESSFULLY.

    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 Required Intervention EZ-28 LENS INJECTOR SYS (B&L)