BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALENS

    MDR report key: 1053270 · Received May 28, 2008

    Report

    Report Number
    2031924-2008-00190
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT THE CRYSTALENS HAPTIC BENT UPON REMOVAL FROM THE LENS CASE. NO PATIENT CONTACT REPORTED, HOWEVER, THE DEVICE HAD BEEN HANDLED BY THE PHYSICIAN. IT IS UNKNOWN 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 011095

    Patients

    Seq Age Sex Outcome Treatment
    1