BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1032771 · Received April 23, 2008

    Report

    Report Number
    2031924-2008-00173
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 28, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. SUTURES.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT THE CRYSTALENS BECAME DAMAGED 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 AND THE PT'S PROGNOSIS IS VERY GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 009781

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention MICROSTAAR LENS INJECTOR (STAAR)