BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON MODEL 815A LENS

    MDR report key: 94652 · Received May 30, 1997

    Report

    Report Number
    57701-1997-00017
    Event Type
    Injury
    Date Received
    May 30, 1997
    Report Date
    May 23, 1997
    Manufacturer
    PHARMACIA PRODUCTION B.V.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CO RECEIVED THIS REPORT AFTER A MODEL 815A LENS WAS RETURNED TO PHARMACIA & UPJOHN FOR AN UNK REASON. IT WAS LABELED WITH A LABEL AND SERIAL NUMBER FOR A MODEL 727A. A MICROSCOPIC EXAMINATION ID IT AS A MODEL 815A. A FOLLOW UP CALL TO THE SURGICAL NURSE AT THE USER FACILITY REPORTED THAT A MALE PT HAD A CEEON MODEL 815A POSTERIOR CHAMBER LENS IMPLANTED ON 20CT96 IN HIS RIGHT EYE. ON 25MAR97 THE 815A LENS WAS EXPLANTED, THE 727A WAS GOING TO BE IMPLANTED, THE POSTERIOR CAPSULAR BAG RUPTURED AND A LENS FELL INTO THE VITREOUS. THE PT HAD RETINAL DETACHMENT (TIME SEQUENCE UNK) THAT NEEDED REPAIR BY ANOTHER SURGEON (A RETINAL SPECIALIST). A VITRECTOMY WAS BEING PERFORMED IN THE SAME SURGERY. DURING THE SURGERY ON 25MAR97 AN ANTERIOR CHAMBER LENS (UNK MFR) WAS THEN IMPLANTED. ADDITIONAL INFO IS BEING SOUGHT FROM THE 2 OPHTHALMOLOGIST'S WHO PERFORMED THE SURGERY ON 24MAR97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON MODEL 815A LENS Implant 1 PIECE PMMA HQL PHARMACIA PRODUCTION B.V. 815A/16.5D 96100029

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention