BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3870102 · Received April 29, 2014

    Report

    Report Number
    2028159-2014-00790
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 2, 2014
    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
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS ONE OF TWO COMPLAINTS REPORTED FOR THIS ISSUE. AS THE CUSTOMER DID NOT RETAIN THE FINISHED GOODS LOT NUMBER, DEVICE HISTORY RECORD (DHR) AND LOT HISTORY COULD NOT BE REVIEWED. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; FUNCTIONAL TESTING COULD NOT BE CONDUCTED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT FOR THE PHACO TIP (UNSPECIFIED PRODUCT) EITHER; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED AS A SAMPLE WAS NOT RETURNED. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADD'L INFO WITH NO RESPONSE TO DATE. (B)(4).

    Description of Event or Problem · 1

    A HEAD OF BIOMEDICAL DEPARTMENT OF A FACILITY REPORTED ASPIRATION ISSUES DURING TWO CATARACT SURGERIES. THE CASSETTE AND THE HANDPIECE WERE CHANGED DURING THE PROCEDURES TO COMPLETE THE SURGERIES. NO SYSTEM MESSAGE WAS DISPLAYED. THERE WAS NO PATIENT HARM. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADD'L INFO WITH NO RESPONSE TO DATE. THIS IS THE SECOND OF TWO MEDICAL DEVICE REPORTS BEING FILED FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256918 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PHACO TIP| PACK INTREPIT PLUS BASIC