BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1002042 · Received February 25, 2008

    Report

    Report Number
    2031924-2008-00086
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    December 12, 2007
    Report Date
    December 12, 2007
    Manufacturer
    EYEONICS, INC.
    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. ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE LENS DAMAGE WAS RELATED TO USE OF THE LENS INJECTOR SYSTEM. OTHER: SUTURES.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT THE CRYSTALENS HAPTIC TORE WHEN DELIVERING THE LENS USING THE STAAR SURGICAL LENS INJECTOR SYSTEM. INTERVENTION WAS PERFORMED INTRAOPERATIVELY TO ENLARGE THE ORIGINAL INCISION, REMOVE THE DAMAGED LENS, AND SUTURE THE INCISION. A SECOND CRYSTALENS WAS IMPLANTED SUCCESSFULLY.

    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 YR Required Intervention LENS INJECTOR SYSTEM (STAAR)