BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON

    MDR report key: 434918 · Received December 23, 2002

    Report

    Report Number
    9614546-2002-00035
    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 INFECTION NOS]. CASE DESCRIPTION: SPONTANEOUS REPORT, CEE ON. LOCLOG # 02-4216-S, ARGUS # 2002136292GB, BATCH # 664242194. A PHYSICIAN REPORTED THE CASE REGARDING A PT WHO HAS HAD THE CEE ON 911 (BATCH NUMBER 664242194) IMPLANTED AFTER CATARACT SURGERY, ON AN UNSPECIFIED DATE THE PT DEVELOPED ENDOPHTHALMITIS WITH COAGULASE NEGATIVE STAPHYLOCOCCI. AT THE TIME OF THE REPORT THE OUTCOME WAS UNKNOWN. THREE OTHER SIMILAR CASES OF ENDOPHTHALMITIS WERE REPORTED FROM THE SAME REPORTER. THE REFERENCE NUMBERS ARE: 02-4214-S, ARGUS 2002136290GB; 02-4215-S, ARGUS 200213629GB; 02-4217-S, ARGUS 2002136291GB. FURTHER INFO IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON INTRAOCULAR LENS HQL PHARMACIA & UPJOHN, GRONINGEN 911A 664242194

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability