BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXOR OPHTHALMIC MICROSCOPES

    MDR report key: 7688843 · Received July 15, 2018

    Report

    Report Number
    2028159-2018-01448
    Event Type
    Malfunction
    Date Received
    July 15, 2018
    Report Date
    November 12, 2018
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE REPORTED EVENT. THE COMPANY SERVICE REPRESENTATIVE FOUND THAT THE BOTTOM ADAPTER WAS LOOSE. THE COMPANY SERVICE REPRESENTATIVE TIGHTENED THE FOUR SCREWS TO RESOLVE THE ISSUE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE SYSTEM WAS MANUFACTURED ON NOVEMBER 1, 2017. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CAN BE ATTRIBUTED TO LOOSE SCREWS ON THE MICROSCOPE STAND. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE REPORTED EVENT. THE COMPANY SERVICE REPRESENTATIVE FOUND THAT THE BOTTOM ADAPTER WAS LOOSE. THE COMPANY SERVICE REPRESENTATIVE TIGHTENED THE FOUR SCREWS TO RESOLVE THE ISSUE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE SYSTEM WAS MANUFACTURED ON NOVEMBER 1, 2017. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CAN BE ATTRIBUTED TO LOOSE SCREWS ON THE MICROSCOPE STAND. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (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 THE MICROSCOPE HEAD IS LOOSE. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530811 LUXOR OPHTHALMIC MICROSCOPES MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC HRM ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other