BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2913586 · Received December 21, 2012

    Report

    Report Number
    2028159-2012-02025
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 27, 2012
    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
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE HAS NOT BEEN RECEIVED FOR EVALUATION. TWO LOT NUMBERS WERE IDENTIFIED WITH THE COMPLAINT. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. THE PRODUCT WAS RELEASED ACCORDING TO MANUFACTURER'S ACCEPTANCE CRITERIA. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE VITRECTOR TIP BROKE OFF WHILE IN USE DURING A VITRECTOMY. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON- IRVINE TECHNOLOGY CENTER XT 1336556H

    Patients

    Seq Age Sex Outcome Treatment
    1 25+ GAUGE TOTAL PLUS PAK 5.0 CPM