BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALENS

    MDR report key: 1060161 · Received June 11, 2008

    Report

    Report Number
    2031924-2008-00222
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS NOTICING THAT THE CRYSTALENS WAS TORN WHEN OPENING THE PACKAGE. THE DEVICE DID NOT CONTACT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 013938

    Patients

    Seq Age Sex Outcome Treatment
    1