BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC IBC

    MDR report key: 1913732 · Received November 12, 2010

    Report

    Report Number
    3002037047-2010-00179
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ALCON - BELGIUM / S.A. ALCON- COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETENTION SAMPLES WERE INSPECTED, AND NO FOREIGN MATERIAL WAS OBSERVED. THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 10/15/2010, 10/20/2010, AND 11/05/2010 BY PHONE AND BY MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A THREADLIKE FOREIGN BODY WAS OBSERVED DURING SURGERY, AND WAS INJECTED INTO THE CHAMBER OF THE PT'S EYE. THE FOREIGN BODY WAS NOT REMOVED AND PER THE SURGEON, THERE WAS NO PT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVISC IBC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM / S.A. ALCON- COUVREUR N.V. NA 10F02A

    Patients

    Seq Age Sex Outcome Treatment
    1