BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 6187661 · Received December 19, 2016

    Report

    Report Number
    1644019-2016-01552
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    December 5, 2016
    Report Date
    March 7, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RETURNED FOR EVALUATION FOR THE REPORT OF DEBRIS IN EYE; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE ROOT CAUSE FOR THE DEFECT EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. (B)(4).

    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 CUSTOMER REPORTED THAT A SMALL PIECE OF DEBRIS WAS SEEN IN THE BACK OF THE EYE DURING A PARS PLANA VITRECTOMY. THE REPORTER INFORMED THAT "THERE WAS NOTHING ELSE OTHER THAN BASIC SALT SOLUTION INJECTED INTO THE EYE DURING THE CASE". ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS CASE. NO UPDATES HAVE BEEN RECEIVED AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A SMALL PIECE OF DEBRIS WAS SEEN IN THE BACK OF THE EYE DURING A PARS PLANA VITRECTOMY . THE REPORTER INFORMED THAT "THERE WAS NOTHING ELSE OTHER THAN BASIC SALT SOLUTION INJECTED INTO THE EYE DURING THE CASE." ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS CASE. NO UPDATES HAVE BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838604 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1875901H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BASIC SALT SOLUTION| TROCAR VALVE