BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3193115 · Received June 25, 2013

    Report

    Report Number
    2028159-2013-01246
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 30, 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 Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED FOR IN HOUSE TESTING. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FLUID/AIR EXCHANGE WAS UNABLE TO BE DONE DURING SURGERY. THERE WERE MULTIPLE ATTEMPTS MADE. AFTER A 15 MINUTE DELAY, AIR WAS INJECTED MANUALLY WITH A SYRINGE TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287885 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON ¿ IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23+ GAUGE TOTAL PLUS PAK