BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3130328 · Received May 22, 2013

    Report

    Report Number
    2028159-2013-00939
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 26, 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
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THERE WAS AN ISSUE WITH THE CASSETTE AND VITRECTOMY PROBE DURING SURGERY. THE ASPIRATION WAS POOR AND THERE WAS A "HISS" SOUND COMING FROM THE CASSETTE. THE PROBE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226552 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR 25+ GAUGE TOTAL PLUS PAK