BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM 2000

    MDR report key: 8695999 · Received June 13, 2019

    Report

    Report Number
    2028159-2019-01083
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 20, 2019
    Report Date
    September 5, 2019
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    NCF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE REPORTED EVENT. THE SCREWS ON THE DOVETAIL WERE TIGHTENED TO RESOLVE THE ISSUE. NO FUNCTIONAL ISSUES WERE NOTED WITH THE SYSTEM. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE ROOT CAUSE CAN BE ATTRIBUTED TO LOOSE DOVETAIL SCREWS. THE DOVETAIL ENABLES THE CUSTOMER TO REMOVE AND REPLACE THE ABERROMETER ONTO THE MICROSCOPE PER THE CUSTOMER¿S PREFERENCE. THUS, IT IS LIKELY THAT CUSTOMER HANDLING ATTRIBUTED TO THE LOOSE DOVETAIL SCREWS. HOWEVER, THIS IS UNABLE TO BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED, THE ABERROMETER WAS MOVED AND THEY COULD NOT GET IT BACK IN ITS PROPER POSITION DUE TO THE LOOSENESS OF THE DOVETAIL SCREW. THE CALIBRATION COULD NOT BE COMPLETED AND THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491784 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1