BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1061282 · Received June 16, 2008

    Report

    Report Number
    2031924-2008-00221
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 12, 2007
    Report Date
    May 21, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. ONE WEEK POSTOPERATIVELY, THE LENS WAS EXCHANGED FOR AN 11.0 D CRYSTALENS (NOTE: THE ORIGINAL LENS IMPLANTED WAS A 16.25 D CRYSTALENS). THE REASON PROVIDED FOR THE LENS EXCHANGE WAS "PATIENT WAS UNCOMFORTABLE WITH LENS, DID NOT FIT WELL". 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. AT52SE 013769

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention