BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON UV-ABSORBING LENS

    MDR report key: 40314 · Received September 26, 1996

    Report

    Report Number
    2083358-1996-00003
    Event Type
    Injury
    Date Received
    September 26, 1996
    Report Date
    September 26, 1996
    Manufacturer
    PHARMACIA IOVISION INC
    Product Code
    HOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE THAT THIS REPORT WAS RECEIVED BY PHARMACIA IOVISION ON 1/4/96. IT WAS BROUGHT TO THE ATTENTION OF CORPORATE PHARMACOVIGILANCE (CPV) ON 9/12/96 FROM SWEDEN. THE CONSULTANT OPINION OF THE REPORT WAS RECEIVED AT PHARMACIA IOVISION ON 7/16/96 AND FORWARDED TO CPV ON 9/27/96. THIS SHOULD CLARIFY MANUFACTRER RECEIVE DATES.

    Description of Event or Problem · 1

    INVESTIGATION BY THE MFR CONSISTED OF A VIDEO THAT WAS REVIEWED AND EVALUATED BY A CONSULTANT. IT WAS THE OPINION OF THE CONSULTANT. IT WAS THE OPINION OF THE CONSULTANT THAT IT WAS APPARENT THAT THE PT SUSTAINED A "CAPSULAR BLOCK PHENOMENON". THIS COMPLICATION IS MORE RELATED TO CAPSULORHEXIS THEN IT IS TO ANY GIVEN LENS IMPLANT. THE OBSERVED SITUATION WAS CAUSED BY THE SURGICAL PROCEDURE. NO FURTHER INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON UV-ABSORBING LENS Implant SILICON PC IOL HOL PHARMACIA IOVISION INC 920 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK * Other| R HEALON