BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXOR OPHTHALMIC MICROSCOPES

    MDR report key: 5673401 · Received May 23, 2016

    Report

    Report Number
    2028159-2016-02151
    Event Type
    Malfunction
    Date Received
    May 23, 2016
    Report Date
    September 29, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HRM
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    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).

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS CONFIRMED THAT THE BOTTOM PLATE OF THE STAND HAD LOOSE SCREWS. THE COMPANY REPRESENTATIVE TIGHTENED THE SCREWS AND FOUND TO MEET PRODUCT SPECIFICATIONS. A REVIEW OF THE CUSTOMER¿S COMPLAINT HISTORY FOR THE LAST 24 MONTHS DID NOT SHOW ANY PREVIOUS COMPLAINTS OF THIS KIND AGAINST THE SYSTEM. THE SYSTEM WAS MANUFACTURED ON MAY 28, 2015. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A LOOSE BOTTOM PLATE ON THE STAND. HOWEVER, HOW THE SCREWS BECAME LOOSE IS INCONCLUSIVE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE MICROSCOPE HEAD WAS LOOSE ON SEVERAL OCCASIONS. A COMPANY REPRESENTATIVE TIGHTENED THE SCREWS AND THIS RESOLVED THE ISSUE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327134 LUXOR OPHTHALMIC MICROSCOPES MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC HRM ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER LX3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other