BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYS OZIL

    MDR report key: 3960022 · Received May 29, 2014

    Report

    Report Number
    2028159-2014-00979
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    AN OPHTHALMIC SURGEON REPORTED THAT ASPIRATION "WAS NOT PERFORMED ON THE WAY OF SURGERY" AND ULTRASOUND WAS POOR DURING A PROCEDURE. THE PROBLEM WAS SOLVED AFTER REPLACING THE CASSETTE WITH ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITH NO IMPACT TO THE PT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315967 INFINITI VISION SYS OZIL PHACOFRAGMENTATION SYS HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1