BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1061201 · Received June 16, 2008

    Report

    Report Number
    2031924-2008-00216
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 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

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LENS WAS DISCARDED BY THE PHYSICIAN AND IS NOT AVAILABLE FOR EVALUATION. ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO PATIENT ANATOMY.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT A PATIENT UNDERWENT CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS. APPROXIMATELY SEVEN WEEKS POSTOPERATIVELY, SECONDARY SURGICAL INTERVENTION WAS PERFORMED IN ORDER TO EXPLANT THE LENS. THE REASON PROVIDED FOR EXPLANT WAS "PATIENT EYE WOULD NOT SUPPORT THE LENS". ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 012531

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention