BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1083375 · Received July 28, 2008

    Report

    Report Number
    2031924-2008-00259
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    June 17, 2008
    Report Date
    July 1, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: ACCORDING TO THE PHYSICIAN, THE ROOT CAUSE OF THE EVENT IS RELATED TO "IRREGULAR IOL".

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT A PT UNDERWENT UNEVENTFUL CATARACT SURGERY WITH PLACEMENT OF THE CRYSTALENS IN THE LEFT EYE. POSTOPERATIVELY, THE PT HAD A REFRACTIVE ERROR. PREOPERATIVE BCVA DECREASED TO 20/40 - 20/50; AFTER SURGERY THE BCVA DECREASED TO 20/400. IN 2008, THE LENS WAS REPOSITIONED AND THE FOLLOWING MONTH, THE LENS WAS EXCHANGED FOR A SECOND CRYSTALENS (22.0 D.) AFTER THE LENS EXCHANGE, THE PT'S BCVA IMPROVED TO 20/40 AND THE PHYSICIAN REPORTS THE PROGNOSIS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTROCULAR LENS HQL EYEONICS, INC. AT50SE 010327

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention