BEUDAMED
    FDA Adverse Event Summary report: N

    CEEON

    MDR report key: 486427 · Received October 1, 2003

    Report

    Report Number
    9614546-2003-00054
    Date Received
    October 1, 2003
    Report Date
    September 24, 2003
    Manufacturer
    PHARMACIA & UPJOHN GRONINGEN BV
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PUPILLARY BLOCK [PUPILLARY DISORDER NOS]. A LITERATURE ARTICLE (GATON DD ET AL, BRITISH JOURNAL OF OPHTHALMOLOGY 2003; 87:1109-1111) REPORTED THAT A PT, SUFFERING FROM ANGLE CLOSURE GLAUCOMA, EXPERIENCED PUPILLARY BLOCK FOLLOWING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) IMPLANTATION. THE LENS WAS IMPLANTED, ON AN UNK DATE, AFTER EXTRACAPSULAR CATARACT EXTRACTION AND FIVE YEARS LATER PUPILLARY BLOCK WAS DIAGNOSED BASED ON THE APPEARANCE OF IRIS BOMBE AND A SHALLOW ANTERIOR CHAMBER WITH A FIXED, NON-REACTING PUPIL AND INCREASED INTRAOCULAR PRESSURE (IOP) UP TO 56MMHG. THE PT WAS TREATED INITIALLY WITH TOPICAL BETA-BLOCKERS, TOPICAL ALFA-ADRENERGIC AGONIST AND LATANOPROST (XALATAN) THEN WITH NEODYMIUM-YAG LASER PERIPHERAL IRIDOTOMY REPEATED TWICE. THE FINAL IOP WAS 6MMHG AND THE VISUAL ACUITY 20/150. THE EVENT PUPILLARY BLOCK IS LISTED VS CDS. THE REPORTING PHYSICIAN CONSIDERED THE EVENT TO BE RELATED TO THE IOL IMPLANTATION. THE COMPANY AGREES ON THAT ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON INTRAOCULAR LENS HQL PHARMACIA & UPJOHN GRONINGEN BV 911A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention