BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1061283 · Received June 16, 2008

    Report

    Report Number
    2031924-2008-00218
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 22, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENTS SPOUSE REPORTS THAT HER HUSBAND UNDERWENT CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS. POSTOPERATIVELY, YAG CAPSULOTOMY WAS PERFORMED AND THEN APPROXIMATELY 3 WEEKS LATER A VITRECTOMY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS EVENT IS BEING REPORTED ON THE BASIS OF UNKNOWN CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention