BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3193139 · Received June 25, 2013

    Report

    Report Number
    2028159-2013-01245
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ALCON ¿ IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED AND IS AWAITING INSPECTION. 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

    A CUSTOMER REPORTED THAT THE PT'S EYE BECAME UNSTABLE WHEN THE IRRIGATION SETTING WAS AT 30 MMHG (MILLIMETER OF MERCURY) AND THE INTRAOCULAR PRESSURE CONTROL WAS NOT BEING USED DURING SURGERY. THE EYE BECAME STABLE WHEN THE IRRIGATION WAS ADJUSTED TO 60 MMHG BUT WHEN ASPIRATION STARTED THE EYE BECAME UNSTABLE AGAIN. THE ISSUE WAS RESOLVED AFTER THE INFUSION CANNULA WAS EXCHANGED. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288742 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON ¿ IRVINE TECHNOLOGY CENTER WITH LASER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25+ GAUGE TOTAL PLUS PAK