BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYS OZIL

    MDR report key: 3960027 · Received May 29, 2014

    Report

    Report Number
    2028159-2014-00948
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 27, 2014
    Report Date
    April 27, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT HAS BEEN PERFORMED AND A SAMPLE HAS BEEN RECEIVED. THE 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). THIS REPORT WAS MAILED TO FDA ON: 05/27/2014. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE VACUUM WAS NOT FINE DURING THE SURGERY. PER REPORTED THE SYS DID NOT DRAIN DURING THE QUADRANT REMOVAL PROGRAM. THE HANDPIECE AND NEEDLE WERE REPLACED. THE SURGERY WAS COMPLETED WITH SOME DELAY BY USING ANOTHER SYS. THERE WAS NO PT IMPACT. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THIS IS THE FIRST OF TWO MED DEVICE REPORTS BEING FILED FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315892 INFINITI VISION SYS OZIL PHACOFRAGMENTATION SYS HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INFINITI FMS CASSETTE