BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1842604 · Received September 1, 2010

    Report

    Report Number
    2028159-2010-01652
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY CALLED IN TO TECHNICAL SERVICES AND A NEW FOOT PEDAL WAS ORDERED. THE FACILITY REPORTED THEY WOULD BE RETURNING THE REPLACED FOOTSWITCH FOR IN-HOUSE TESTING. 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

    ADVERSE EVENT(S): "NO PATIENT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "UNABLE TO REFLUX WITH FOOTSWITCH" (REFLUX WITHIN DEVICE). A NURSE REPORTED THE SURGEON WAS UNABLE TO "REFLUX" WITH THE FOOTSWITCH. THE STAFF MANUALLY "REFLUXED" BY SQUEEZING THE TUBING TOWARD THE EYE, CLEARING THE OCCLUSION. THE CASE WAS COMPLETED. THERE WAS NO PATIENT IMPACT, DELAYS, OR CANCELLATIONS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1