BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1032783 · Received April 23, 2008

    Report

    Report Number
    2031924-2008-00160
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    January 16, 2008
    Report Date
    March 28, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT THE CRYSTALENS SEEMED TO STICK TO THE PACKAGING AND HE NOTICED THE LENS HAPTIC WAS TORN UPON REMOVAL FROM THE PACKAGING (PRIOR TO LOADING IN THE CARTRIDGE). NO PT CONTACT REPORTED, HOWEVER, THE DEVICE HAD BEEN HANDLED BY THE PHYSICIAN. IT IS UNK WHETHER THE LENS DAMAGE WAS CAUSED BY HANDLING OR WAS PRESENT PRIOR TO HANDLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 009837

    Patients

    Seq Age Sex Outcome Treatment
    1