BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON UV-ABSORBING PC IOL

    MDR report key: 50203 · Received November 15, 1996

    Report

    Report Number
    2083358-1996-00006
    Event Type
    Injury
    Date Received
    November 15, 1996
    Date of Event
    October 3, 1996
    Report Date
    November 13, 1996
    Manufacturer
    PHARMACIA IOVISION, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CO WAS NOTIFIED BY AN OPHTHALMOLOGIST OF 2 WOMEN WHO DEVELOPED ENDOPHTHALMITIS AFTER IMPLANTATION OF THE UV-ABSORBING LEAVE IN LENS. ONE WOMAN HAD A CATARACT EXTRACTION (LEFT EYE) AND IMPLANT OF THE MODEL 920 IOL ON 9/30/96. ONE DAY POSTOPERATIVE EXAM BY SLIT LAMP REVEALED 2+ CELLS AND 1+ FLARE. A DIAGNOSIS OF ENDOPHTHALMITIS WAS MADE AND A VITRECTOMY PERFORMED ON 10/4/96. THE LEFT EYE WAS PATCHED, ANTIBIOTICS STARTED, AND SHE WAS HOSPITALIZED FOR 24 HRS. THE DR'S CALL WAS PROMPTED BY A REQUEST FOR INFO AS TO THE OCCURRENCE OF ENDOPHTHALMITIS. BOTH EYE IMPLANTS WERE DONE WITHIN 2 WKS OF EACH OTHER AT DIFFERENT LOCATIONS, AND DIFFERENT INSTRUMENTS WERE USED IN EACH CASE. THE ONLY COMMON FACTOR WAS THE UV-ABSORBING LENS, MODEL 920. FOLLOW-UP INFO IS BEING SOUGHT AS WELL AS THE OUTCOME OF THE ENDOPHTHALMITIS. MFR INVESTIGATION OF THE BATCH RECORDS WAS PERFORMED. ALL ACCEPTANCE CRITERIA WAS MET; LABORATORY REPORTS WERE REINSPECTED AND NO DISCREPANCIES NOTED; ALL RELEASE CRITERIA WERE MET AND TOXICITY STUDIES FURTHER SUPPORT THAT THE PRODUCT IS NOT RESPONSIBLE FOR THE ENDOPHTHALMITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON UV-ABSORBING PC IOL Implant IOL HQL PHARMACIA IOVISION, INC. 920 IOL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention