BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM 2000

    MDR report key: 7073102 · Received November 30, 2017

    Report

    Report Number
    2028159-2017-04443
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Report Date
    April 6, 2018
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    NCF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND THE ISSUE TO BE A THIRD-PARTY LOOSE FEMALE DOVETAIL THAT ATTACHES TO THE BOTTOM OF THE MICROSCOPE. THERE WAS NO ISSUE IDENTIFIED WITH THE SYSTEM DOVETAIL ATTACHED TO THE ABERROMETER. THE COMPANY SERVICE REPRESENTATIVE PLACED THE THREAD LOCKER ONTO THE THIRD-PARTY DOVETAIL AND REALIGNED THE ABERROMETER TO THE MICROSCOPE. THE THIRD-PARTY DOVETAIL WAS RECENTLY REPLACED BY THE CUSTOMER, WHICH LIKELY ATTRIBUTED TO THE REPORTED EVENT. THE COMPANY SERVICE REPRESENTATIVE ADVISED THE CUSTOMER TO NOTIFY COMPANY OF WORK PERFORMED ON THE MICROSCOPE AND THIRD-PARTY DOVETAIL SO THAT COMPANY CAN VERIFY THE SYSTEM PERFORMS AS INTENDED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A THIRD-PARTY PART THAT IS NOT MANUFACTURED BY OUR COMPANY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED A LOOSE ABERROMETER DOVETAIL OBSERVED BEFORE A SURGICAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852823 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other