BEUDAMED
    FDA Adverse Event Summary report: N

    CEEON EDGE

    MDR report key: 434269 · Received December 16, 2002

    Report

    Report Number
    9614546-2002-00032
    Date Received
    December 16, 2002
    Date of Event
    December 4, 2002
    Report Date
    December 16, 2002
    Manufacturer
    PHARMACIA & UPJOHN, GRONINGEN
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IRITIS [IRITIS]. A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT PHACOEMULSIFICATION WITH CEEON EDGE 911A (INTRA-OCULAR LENS). IMPLANTATION TOOK PLACE IN 2002. THE POSTOPERATIVE PERIOD WAS UNEVENTFUL UP UNITL DEC 2002. THE PATIENT SUFFERED WITH SEVERE IRITIS. THE PATIENT'S PUPILS WERE DILATED WITH ATROPINE EYEDROPS DROP (ATROPINE, DOSE UNKNOWN) AND STEROIDS (DEXAMETHASONE, 2ML INJECTION), WHICH WERE ADMINISTERED IN 2002 AND TWELVE HOURS LATER. THE PATIENT DEVELOPED ACIDITY AND HIC-COUGHS AS A SYSTEMIC SIDE EFFECT OF THE DEXAMETHASONE AND THEREFORE DEXAMETHASONE WAS STOPPED. THE PATIENT STARTED RECOVERING 2 DAYS LATER AND ONWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON EDGE INTRAOCULAR LENS HQL PHARMACIA & UPJOHN, GRONINGEN 911A, 21.5 D 660918

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability