BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1080206 · Received July 22, 2008

    Report

    Report Number
    2031924-2008-00263
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 23, 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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE ROOT CAUSE OF THE LENS DAMAGE WAS RELATED TO USE OF THE LENS INJECTOR SYSTEM.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT THE CRYSTALENS TRAILING HAPTIC TORE WHEN DELIVERING THE LENS USING THE STAAR SURGICAL LENS INJECTOR SYSTEM. DELIVERY WAS ATTEMPTED WITH A SECOND AND THIRD CRYSTALENS, HOWEVER, THESE LENS HAPTICS ALSO TORE. INTERVENTION WAS PERFORMED INTRAOPERATIVELY TO ENLARGE THE ORIGINAL INCISION, REMOVE THE DAMAGED LENSES, AND SUTURE THE INCISION. A FOURTH CRYSTALENS WAS IMPLANTED SUCCESSFULLY AND THE PATIENT'S PROGNOSIS IS GOOD; AT THE LAST VISIT ON 7/1/08, THE PATIENT'S BCVA WAS 20/20. REFERENCE # 2031924-2008-00238 AND #2031924-2008-00262.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 010171

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention MICROSTAAR LENS INJECTOR SYSTEM (STAAR SURGICAL)