BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL II

    MDR report key: 3915538 · Received June 4, 2014

    Report

    Report Number
    2028159-2014-01069
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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). REPORTED MAILED TO FDA 06/06/2014. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTS DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THE SYSTEM KEPT SHUTTING DOWN. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SYSTEM WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325779 UNIVERSAL II PHACOEMULSIFICATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR UNIV II NA

    Patients

    Seq Age Sex Outcome Treatment
    1