BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON LENS

    MDR report key: 118564 · Received September 5, 1997

    Report

    Report Number
    2083358-1997-00006
    Event Type
    Injury
    Date Received
    September 5, 1997
    Date of Event
    June 1, 1997
    Report Date
    August 7, 1997
    Manufacturer
    PHARMACIA IOVISION, INC.
    Product Code
    HOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM AN EYE SURGERY CENTER CALLING FOR INFO CONCERNING INFECTIONS OCCURRING WITH INTRAOCULAR LENS IMPLANTS WITH THE MODEL 920 UV-ABSORBING SILICONE FOLDABLE LENS. A PHYSICIAN HAS HAD THREE OCCURRENCES OF ENDOPHTHALMITIS ASSOCIATED WITH THIS MODEL INTRAOCULAR LENS WITHIN THE PAST TWO MONTHS. THIS PARTICULAR WOMAN HAD A PHACO, CLEAR CORNEAL, CATARACT EXTRACTION, LEFT EYE 5/28/97. SUBSEQUENTLY, SHE DEVELOPED ENDOPHTHALMITIS (DATE UNK). SHE WAS TREATED PRE AND POST OPERATIVELY WITH TOBREX DROPS. A CULTURE WAS POSITIVE FOR STREP AND AN ANTIBIOTIC PRESCRIBED. THE EYE SURGERY CENTER CONDUCTED AN INTERNAL INVESTIGATION TO DETERMINE THE CAUSE, HOWEVER, NO SOURCE OF THE INFECTION COULD BE FOUND. A MFR REVIEW OF THE BATCH RECORDS REVEALED THAT ALL RELEASE CRITERIA WERE MET, NO DISCREPANCIES WERE NOTED IN LABORATORY REPORTS, AND ALL RELEASE CRITERIA WERE MET. THE RESULTS SHOW THAT THE PRODUCT IS NOT RESPONSIBLE FOR THE ENDOPHTHALMITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON LENS Implant UV-ABSORBING SILICONE FOLDABLE INTRAOCULAR LENS HOL PHARMACIA IOVISION, INC. 920 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention TOBREX (PRE AND POST OP)