BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEE ON LENSES

    MDR report key: 155003 · Received March 6, 1998

    Report

    Report Number
    2030635-1998-00007
    Event Type
    Malfunction
    Date Received
    March 6, 1998
    Date of Event
    January 14, 1998
    Report Date
    February 6, 1998
    Manufacturer
    PHARMACIA IOVISION, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED VIA A LENS RETURN CONCERNING THE MODEL 920 CEEON LENS. THE PACKAGING OF THE LENS WAS OPENED FOR USE AND IT WAS NOTED THAT THE HAPTIC WAS BROKEN. UPON FOLLOW-UP WITH THE PHYSICIAN, HE CONFIRMED THAT WHEN THE PACKAGE WAS OPENED, THE HAPTIC WAS FOUND TO BROKEN. THE LENS WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND THE RESULTS HAVE BEEN ATTACHED TO THIS SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEE ON LENSES Implant FOLDABLE SILICONE INTRAOCULAR LENS HQL PHARMACIA IOVISION, INC. 920 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA