BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1071607 · Received July 9, 2008

    Report

    Report Number
    2031924-2008-00245
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 13, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P0300002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: THE DEVICE WILL NOT BE RETURNED, HOWEVER, THE EVENT WAS ATTRIBUTED TO AN INCORRECT DIOPTER SELECTION.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTS THAT A PT 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 17.25 D CRYSTALENS). THE REASON PROVIDED FOR THE LENS EXCHANGE WAS "WRONG SIZE". THE LENS WAS EXCHANGED SUCCESSFULLY AND THE PT'S PROGNOSIS IS GOOD. ADD'L INFO 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 007746

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention