BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1854133 · Received September 2, 2010

    Report

    Report Number
    2028159-2010-01679
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 3, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "NO AIR FLOW" (NO FLOW). A CUSTOMER REPORTED THAT NO AIR FLOW WAS NOTED WHEN TURNING ON THE FLUID/AIR EXCHANGE (FAX). THE SURGEON INCREASED THE FAX TO 50MMHG, BUT STILL NO AIR FLOW. LASER TREATMENT WAS POSTPONED. THE AIR WAS FOUND TO BE FLOWING WHEN THE CUSTOMER TESTED THE FAX AFTER SURGERY. THE PATIENT'S SURGERY WAS COMPLETED ON (B)(6) 2010 AND THE PATIENT IS DOING WELL.

    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