BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC

    MDR report key: 2450529 · Received February 3, 2012

    Report

    Report Number
    3002037047-2012-00026
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 4, 2012
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED. THE BATCH RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FIBROUS PARTICULATE WAS FOUND IN THE SOLUTION IN THE PATIENT'S EYE DURING USAGE. IT WAS IMMEDIATELY REMOVED DURING THE SAME PROCEDURE AND THERE WAS NO HARM TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1