BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1080207 · Received July 22, 2008

    Report

    Report Number
    2031924-2008-00239
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 23, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE ROOT CAUSE OF THE LENS DAMAGED WAS RELATED TO USE OF THE LENS INJECTOR SYSTEM, WHERE THE LENS WAS LOADED INCORRECTLY.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT THE CRYSTALENS BECAME DAMAGED WHEN IMPLANTING THE LENS USING THE STAAR SURGICAL LENS INJECTOR SYSTEM. INTERVENTION WAS PERFORMED INTRAOPERATIVELY TO ENLARGE THE ORIGINAL INCISION AND REMOVE THE DAMAGED LENS. A SECOND CRYSTALENS WAS IMPLANTED SUCCESSFULLY AND THE PATIENT'S PROGNOSIS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 010657

    Patients

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