BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3970631 · Received June 2, 2014

    Report

    Report Number
    2028159-2014-01028
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    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
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING THE CATARACT SURGERY, BUBBLES WERE RELEASED FROM THE VITRECTOMY PROBE. THE PROBLEM WAS RESOLVED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320944 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 23 GAUGE 5.0 CUTS PER MINUTE PREMIUM PAK