BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1053283 · Received May 28, 2008

    Report

    Report Number
    2031924-2008-00195
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 2, 2008
    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

    .

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT THE CRYSTALENS HAPTIC BECAME DAMAGED WHEN DELIVERING 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 007207

    Patients

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