BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 946750 · Received November 14, 2007

    Report

    Report Number
    2031924-2007-00340
    Event Type
    Injury
    Date Received
    November 14, 2007
    Date of Event
    October 17, 2007
    Report Date
    October 17, 2007
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE LENS DAMAGE WAS RELATED TO USE OF THE LENS INJECTOR SYSTEM AND HANDLING, WHERE THE LENS WAS IMPROPERLY LOADED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT THE CRYSTALENS HAPTICS TORE WHEN DELIVERING THE LENS USING THE STAAR SURGICAL LENS INJECTOR SYSTEM. IMPLANTATION WAS ATTEMPTED WITH TWO BACKUP CRYSTALENS IOLS; HOWEVER, THESE LENSES ALSO TORE. INTERVENTION WAS PERFORMED INTRAOPERATIVELY TO REMOVE THE DAMAGED LENS, ENLARGE THE ORIGINAL INCISION, AND SUTURE THE INCISION. A FOURTH IOL (NON-CRYSTALENS) WAS IMPLANTED SUCCESSFULLY. REFERENCE MEDWATCH #2031924-2007-00339 AND 2031924-2007-00341.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 009349

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention MICROSTAAR LENS INJECTOR SYSTEM (STAAR)