BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3072601 · Received April 19, 2013

    Report

    Report Number
    2028159-2013-00736
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 23, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT "ABNORMAL OCCLUSION EVENTS" WERE OBSERVED DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE; IT WAS REPORTED THAT THE UNIT KEPT GIVING THE OCCLUSION ALARM DURING PHACOEMULSIFICATION IN THE SCULPT SETTING. THE CASE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170080 INFINITI VISION SYSTEM OZIL PHACOFRAMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1