BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2982466 · Received February 26, 2013

    Report

    Report Number
    2028159-2013-00289
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED, BUT RECEIVED, BUT HAS NOT YET BEEN EVALUATED. 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED 10 MINUTES INTO A VITREOUS SURGERY, FOLLOWING A CATARACT SURGERY, THE INTRAOCULAR VISIBILITY BECAME POOR BECAUSE OF AIR COMING IN FROM THE INFUSION LINE. THE ASSISTANT WAS ABLE TO SEE AIR COMING IN FROM THE AUTO STOPCOCK. THE PHYSICIAN STOPPED THE SURGERY. THE SURGERY WAS RE-STARTED, AIR APPEARED IN THE INFUSION LINE AGAIN AND IT CAME INTO VITREOUS CAVITY. THE PHYSICIAN TRIED TO REMOVE AIR USING PRESSURE BUT WAS UNSUCCESSFUL. HE TRIED TO REMOVE IT WITH A SYRINGE BUT THE AIR WAS NOT ABLE TO BE REMOVED. THE PROCEDURE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81800 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention TOTAL PLUS PAK 25+ 5.0 CPM VALVED STANDARD