BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEEON

    MDR report key: 150255 · Received February 11, 1998

    Report

    Report Number
    2030635-1998-00005
    Event Type
    Malfunction
    Date Received
    February 11, 1998
    Date of Event
    December 2, 1997
    Report Date
    December 4, 1997
    Manufacturer
    PHARMACIA IOVISION, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A LENS WAS RETURNED TO PHARMACIA & UPJOHN WITH A COMPLAINT THAT THE HAPTIC CRIMPED AND THE LENS WAS CUT IN HALF TO REMOVE IT. MULTIPLE ATTEMPTS TO CONTACT THE PHYSICIAN FOR FURTHER INFORMATION BY PHONE WERE UNSUCCESSFUL. A BATCH REVIEW AND ANALYSIS OF THE LENS IS UNDERWAY. THIS CASE REMAINS UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON Implant UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS HQL PHARMACIA IOVISION, INC. 912 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR