BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON

    MDR report key: 434925 · Received December 23, 2002

    Report

    Report Number
    9614546-2002-00037
    Event Type
    Injury
    Date Received
    December 23, 2002
    Report Date
    November 26, 2002
    Manufacturer
    PHARMACIA & UPJOHN, GRONINGEN
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ENDOPHTHALMITS[EYE INFECTION NOS]. CASE DESCRIPTION: SPONTANEOUS REPORT/LOC. REF.N 02-4217-S. ARGUS N. 2002136291GB (CROSS REFERENCE WITH CASES N. 2002136290GB, 2002136292GB, 2002196294GB). A CONSULTANT OPHTHALMOLOGIST REPORTED THAT PT UNDERWENT AN IMPLANTATION WITH CEEON 911 (INTRA-OCULAR LENS BATCH NUMBER 657310058). ON UNKNOWN DAY THE PT DEVELOPED ENDOPHTHALMITIS. PT'S CONDITION WAS UNKNOWN. IN THE PAST THE PT HAD ANOTHER SURGICAL OPERATION DUE TO CATARACT. FURTHER INFO WILL BE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON INTRAOCULAR LENS HQL PHARMACIA & UPJOHN, GRONINGEN 911A 657310058

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability