BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTALLATION VISION SYS

    MDR report key: 4152473 · Received October 6, 2014

    Report

    Report Number
    2028159-2014-01838
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ALCON -IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 SURGEON REPORTED 2 PTS WITH SOFT EYES DURING A VITRECTOMY PROCEDURE AFTER THE INFUSION STOPPED AND THE PRESSURE DROPPED TO ZERO. INFUSION RESUMED AND THE SURGERY WAS COMPLETED WITH THE SAME SYSTEM. THERE WAS NO HARM REPORTED TO THE PATIENTS HOWEVER, BOTH PATIENTS SUSTAINED "LENS DINGS" WHICH CURRENTLY ARE NOT CAUSING ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622182 CONSTALLATION VISION SYS UNIT, PHACOFRAGMENTATION HQC ALCON -IRVINE TECH CTR LXT BA

    Patients

    Seq Age Sex Outcome Treatment
    1