BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUOVISC

    MDR report key: 1212563 · Received October 24, 2008

    Report

    Report Number
    3002037047-2008-00085
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVAL. PRODUCT HISTORY RECORDS WERE REVIEWED, ALL TEST RESULTS WERE WITHIN SPECIFICATION; THERE WERE NO ABNORMAL FINDINGS IN THE RECORDS. THE PACKAGE INSERT STATES, "AS WITH MOST VISCOELASTICS, A TRANSIENT RISE IN INTRAOCULAR PRESSURE HAS BEEN REPORTED IN SOME CASES". ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A SURGEON REPORTED TWO CASES OF POSTOPERATIVE OCULAR HYPERTENSION ONE DAY FOLLOWING CATARACT SURGERY. AT FOUR TO FIVE DAYS FOLLOWING SURGERY, A CLOUDY ANTERIOR CHAMBER WAS OBSERVED. THIS IS THE FIRST OF TWO MEDICAL DEVICE REPORTS BEING FILED FOR THIS REPORT -- THIS REPORT IS FOR THE FIRST PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUOVISC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V. NA 08F03J

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention BETA BLOCKER| DIAMOX