BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 6067299 · Received October 31, 2016

    Report

    Report Number
    1644019-2016-01382
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    October 18, 2016
    Report Date
    January 24, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE RELATED DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION INDICATES THERE ARE (B)(4) ADDITIONAL COMPLAINTS ASSOCIATED WITH THE LOT FOR THE REPORTED ISSUE. NO SAMPLE HAS BEEN RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO SAMPLE WAS RETURNED AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA, THEREFORE, THE ROOT CAUSE FOR THE DEFECT EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. AN INVESTIGATION HAS BEEN COMPLETED AND ACTIONS HAVE BEEN IMPLEMENTED IN ORDER TO IMPROVE PERFORMANCE OF THE VALVES. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS TO EVALUATE EFFECTIVENESS OF ACTIONS TAKEN. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT LEAKAGE OCCURRED FROM THE TROCAR CANNULA. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE TROCAR WITH ANOTHER ONE. THERE WAS NO PATIENT HARM. THE PRODUCT SAMPLE WAS DISCARDED BY THE FACILITY; THEREFORE, A SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718368 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1776613H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CONSTELLATION VISION SYSTEM