BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2801421 · Received October 18, 2012

    Report

    Report Number
    2028159-2012-01594
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE EVAL IS IN-PROGRESS AT THIS TIME. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. PENDING SAMPLE EVAL. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE SHAFT CAME LOOSE FROM A 25 GAUGE CUTTER DURING SURGERY. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25+GAUGE ULTRA VIT PROBE