BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYS

    MDR report key: 3893683 · Received June 4, 2014

    Report

    Report Number
    2028159-2014-01064
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ALCON -IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REP REPORTED A SURGEON USED UNDILUTED SF6 GAS, DISPENSED FROM THE SYSTEM IN A PT'S EYE DURING A VITRECTOMY PROCEDURE. THE CASE WAS COMPLETED, HOWEVER, THE PT REQUIRED ADDITIONAL TREATMENT TO MITIGATE OR RESOLVE ANY POTENTIAL PERMANENT EYE INJURY. NO ADDITIONAL INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327345 CONSTELLATION VISION SYS UNIT, PHACOFRAGMENTATION HQC ALCON -IRVINE TECH CTR TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SF6 GAS