BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON

    MDR report key: 434899 · Received December 23, 2002

    Report

    Report Number
    9614546-2002-00036
    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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ENDOPHTHALMITIS[EYE INFECTIN NOS]. CASE DESCRIPTION: SPONTANEOUS CASE, CEEON LENSES (MODEL 911), LOCAL REF N. 02-4215-S. ARGUS N. 136294GB. CROSS REF. N. 2002136290GB, 2002136291GB AND 2002136292GB. A PHYSICIAN REPORTED A CASE REGARDING PT WHO UNDERWENT A CEEON LENS IMPLANTATION FOLLOWING A CATARACT SURGERY. ON UNKNOWN DATE PT DEVELOPED ENDOPHTHALMITIS WITH COAGULASE NEGATIVE STAPHYLOCOCCI. THE BATCH N. FOR THE LENSES USED WAS 664820056. AT THE TIME OF THIS REPORT THE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON INTRAOCULAR LENS HQL PHARMACIA & UPJOHN, GRONINGEN 911A 664820056

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Disability