BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 4240315 · Received October 29, 2014

    Report

    Report Number
    2028159-2014-02008
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 2, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. THIS IS THE SECOND COMPLAINT FOR THE FINISH GOODS LOT; HOWEVER, THE FIRST FOR THIS ISSUE. THE ORDER WAS BUILT AND RELEASED PER SPECIFICATION. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; VISUAL INSPECTION OR FUNCTIONAL TESTING COULD NOT BE CONDUCTED. A SAMPLE WAS NOT RETURNED FOR THIS COMPLAINT. WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. NO FURTHER INFORMATION IS EXPECTED FOR THIS CASE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE IOP (INTRAOCULAR PRESSURE) CONTROL WAS UNABLE TO BE USED AFTER BEGINNING THE PROCEDURE. THE CASSETTE WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE COMPLETED. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691253 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER TABLETOP-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 GAUGE, 5.0 CUTS PER MINUTE, 0.9 VALVED,| COMBINED PAK