BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYS OZIL

    MDR report key: 4173185 · Received October 10, 2014

    Report

    Report Number
    2028159-2014-01881
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED EXPERIENCING POOR ASPIRATION DURING SURGERY. THE CASSETTE WAS EXCHANGED, AND THE CASE WAS COMPLETED WITHOUT PT HARM. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642704 INFINITI VISION SYS OZIL PHACOFRAGMENTATION SYS HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK