BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL II

    MDR report key: 3970638 · Received June 2, 2014

    Report

    Report Number
    2028159-2014-01027
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    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 ADDITION REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 06/04/2014. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED EXPERIENCING PROBLEMS WITH ASPIRATION DURING A CATARACT PROCEDURE. THE CASE WAS COMPLETED WITH AN ALTERNATE SYSTEM. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321134 UNIVERSAL II PHACOEMULSIFICATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER UNIV II NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK