BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2020541 · Received February 10, 2011

    Report

    Report Number
    2028159-2011-00086
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 10, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYS AND REPLACED THE FLUIDICS MECHANISM ASSEMBLY (FMA) TO CORRECT THE ISSUE WITH LOW VACUUM. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE SAMPLE HAS BEEN RECEIVED AND IN-HOUSE EVAL IS IN PROGRESS. 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

    THE CUSTOMER REPORTED EXPERIENCING A SYS MESSAGE AND LOW INTERMITTENT VACUUM DURING A CATARACT EXTRACTION PROCEDURE. THE SURGERY WAS COMPLETED THE SAME DAY WITHOUT HARM OR INJURY TO THE PT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1