BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1061284 · Received June 16, 2008

    Report

    Report Number
    2031924-2008-00228
    Event Type
    Injury
    Date Received
    June 16, 2008
    Report Date
    May 30, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT REPORTS THAT A PATIENT UNDERWENT CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS. POSTOPERATIVELY, THE LENS WAS EXCHANGED FOR A 20.0 D CRYSTALENS (NOTE: THE ORIGINAL LENS IMPLANTED WAS A 20.25 D CRYSTALENS). THE REASON PROVIDED FOR THE LENS EXCHANGE WAS BLURRY VISION. THE LENS WAS EXCHANGED SUCCESSFULLY AND THE PATIENT'S PROGNOSIS IS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 008679

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention