BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2043041 · Received March 25, 2011

    Report

    Report Number
    2028159-2011-00286
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Report Date
    February 25, 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

    ADDITIONAL INFO REGARDING PRODUCT EVAL IS PENDING; HANDPIECE RETURNED FOR EVAL. 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 THAT THEIR BACK UP PHACO HANDPIECE HAD A VACUUM ISSUE. ADDITIONAL INFO RECEIVED INDICATED THAT THE VACUUM ISSUE OCCURRED DURING A PROCEDURE. THE SYSTEM WAS SWITCHED OUT TO CONCLUDE THE SURGERY WITHOUT INJURY OR HARM TO THE PT.

    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