BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2214089 · Received July 20, 2011

    Report

    Report Number
    2028159-2011-00811
    Event Type
    Other
    Date Received
    July 20, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE ONE SIMILAR REPORT(S) FOR THIS SYSTEM. THE ROOT CAUSE IS UNK. AN INTERNAL INVESTIGATION HAS BEEN OPENED FOR REPORTS OF THE AUTO INFUSION VALVE NOT SWITCHING TO AIR DURING FLUID AIR EXCHANGE (FAX). (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE SYSTEM SUDDENLY LOST PRESSURE AND THE PT'S CHAMBER COLLAPSED WHILE PERFORMING THE AIR/FLUID EXCHANGE DURING A VITRECTOMY PROCEDURE. THE SYSTEM'S PRESSURE WAS INCREASED AND THE ANTERIOR CHAMBER STABILIZED. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PT'S OUTCOME IS REPORTED AS GOOD WITH NO ADVERSE EFFECTS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other