BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1032156 · Received April 21, 2008

    Report

    Report Number
    2031924-2008-00150
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    November 15, 2007
    Report Date
    January 22, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 EITHER RELATED TO USE OF THE LENS INJECTOR SYS OR THE LENS WAS RECEIVED DAMAGE. SUTURES.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT THE CRYSTALENS TRAILING HAPTIC TORE WHEN DELIVERING THE LENS IN THE EYE USING THE STAAR SURGICAL LENS INJECTOR SYSTEM. INTERVENTION WAS PERFORMED INTRAOPERATIVELY TO REMOVE THE DAMAGED LENS AND SUTURE THE INCISION. A SECOND LENS 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 EYEONICS, INC. AT50SE 006584

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LENS INJECTOR SYS (STAAR)