BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1230040 · Received November 12, 2008

    Report

    Report Number
    2031924-2008-00315
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 14, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THE DAMAGED LENS WAS RETURNED TO B&L AND EVALUATED. THE VISUAL INSPECTION UNDER MICROSCOPIC MAGNIFICATION REVEALED THAT THE HAPTIC WAS TORN NEAR THE HINGE. THE FINDINGS ARE CONSISTENT WITH DAMAGE CAUSED BY LENS INJECTOR USE. ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE LENS DAMAGE WAS RELATED TO USE OF THE LENS INJECTOR SYSTEM.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT THE CRYSTALENS HAPTIC TORE DURING INSERTION USING THE STAAR SURGICAL LENS INJECTOR SYSTEM. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE ORIGINAL INCISION AND REMOVE AND REPLACE THE LENS INTRAOPERATIVELY. A SECOND CRYSTALENS WAS IMPLANTED SUCCESSFULLY AND THE PT'S PROGNOSIS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL BAUSCH & LOMB AT52SE 009718

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (STAAR SURGICAL)| MICROSTAAR LENS INSERTION INSTRUMENT