BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYS OZIL

    MDR report key: 4173140 · Received October 10, 2014

    Report

    Report Number
    2028159-2014-01856
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 19, 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
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT WAS PERFORMED AND 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. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE CONTINUOUS OCCLUSION ISSUES WHILE USING THE SYS WITHOUT SYS MESSAGE DISPLAY. THE EVENT OCCURRED DURING FIVE SURGERIES WITH THE SAME SYS BUT WITH FIVE DIFFERENT CASSETTES, FIVE DIFFERENT HANDPIECES AND FIVE DIFFERENT NEW STERILIZATION PIECES. THE FIVE CASSETTES PASSED THE PRIMING TESTS WITHOUT ANY PROBLEM. THE PT IMPACT IS UNK. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643195 INFINITI VISION SYS OZIL PHACOFRAGMENTATION SYS HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED SURGICAL PRODUCTS| UNSPECIFIED CASSETTES| UNSPECIFIED HANDPIECES