BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSEM OZIL

    MDR report key: 4152561 · Received October 6, 2014

    Report

    Report Number
    2028159-2014-01827
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    September 12, 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
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT WAS PERFORMED. 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 INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT THE SYSTEM WAS NOT CUTTING CORRECTLY DURING A PHACOEMULSIFICATION PROCEDURE ON A PATIENT. THEREFORE THE SURGEON DID NOT USE THIS CUTTER TO CUT INTO THE EYE, BUT INSTEAD COMPLETED THE PROCEDURE WITH BLADES. THE PATIENT IMPACT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622142 INFINITI VISION SYSEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1