BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAUREATE WORLD PHACO SYSTEM

    MDR report key: 3941849 · Received June 3, 2014

    Report

    Report Number
    2028159-2014-00854
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A VITREOUS CUTTER DID NOT WORK DURING A PROCEDURE. THE CUTTER WAS EXCHANGED MULTIPLE TIMES WITH NO SUCCESS. THE SURGEON CONVERTED TO A MANUAL VITRECTOMY TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324189 LAUREATE WORLD PHACO SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER LAUREATE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LAUREATE ANTERIOR VIT HP