BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM 2000

    MDR report key: 7935195 · Received October 4, 2018

    Report

    Report Number
    2028159-2018-02090
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    September 10, 2018
    Report Date
    December 13, 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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ABERROMETER IS MOUNTED UNDERNEATH THE MICROSCOPE VIA A DOVETAIL THAT IS ATTACHED TO THE ABERROMETER (MALE), AND A MOUNTING BRACKET (FEMALE) THAT IS CORRESPONDINGLY ATTACHED UNDERNEATH THE MICROSCOPE. THE DOVETAIL AND MOUNTING BRACKET ASSEMBLY ENABLES THE CUSTOMER TO REMOVE AND REPLACE THE ABERROMETER PER THE CUSTOMER¿S DISCRETION. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO LOOSE SCREWS. 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 A LOOSE DOVETAIL ON THE ABERROMETER. THE CUSTOMER NOTED THAT THE DOVETAIL HAS ALWAYS BEEN LOOSE AND DIDN'T SEEM NORMAL. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775235 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1