BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON UV-ABSORBING SILICONE PC IOL MODEL 920

    MDR report key: 98527 · Received June 12, 1997

    Report

    Report Number
    2083358-1997-00003
    Event Type
    Injury
    Date Received
    June 12, 1997
    Date of Event
    April 14, 1997
    Report Date
    June 5, 1997
    Manufacturer
    PHARMACIA IOVISION, INC.
    Product Code
    MFK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CO RECEIVED A REPORT FROM A NURSE AT AN EYE INSTITUTE THAT A FEMALE PT HAD A CEEON MODEL 920 INTRAOCULAR LENS IMPLANTED AND THEN EXPLANTED DURING THE SAME SURGERY ON 4/14/97. THE SURGEON NOTICED THAT THE HAPTIC HAD BROKEN DURING THE SURGERY. HE HAD TO CUT THE LENS IN HALF TO REMOVE IT BEFORE REPLACING IT WITH A DIFFERENT LENS. ACCORDING TO THE REPORTER THE INCISION DID NOT HAVE TO BE ENLARGED AS FAR AS SHE KNEW AND THE PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. F/U INFO RECEIVED FROM THE SURGEON ON 6/3/97 INDICATED THAT SURGICAL INTERVENTION, THAT IS A LARGER INCISION WAS MADE, WAS NECESSARY IN ORDER TO REMOVE THE LENS. HE WROTE THAT THE OPERATING TIME WAS PROLONGED AND IT WAS VERY DIFFICULT FOR HIM TO CUT THE LENS IN TWO. AN ANALYSIS OF THE RETURNED LENS BY OUR QUALITY ASSURANCE DEPT INDICATED ONE OF THE HAPTICS HAD BEEN CUT AND THAT THE LENS HAD BEEN CUT IN HALF FOR THE PURPOSE OF EXPLANTATION. NO FURTHER INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON UV-ABSORBING SILICONE PC IOL MODEL 920 Implant 3 PIECE FOLDABLE SILICONE LENS MFK PHARMACIA IOVISION, INC. 920/22.5 D UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention