BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM 2000

    MDR report key: 10245666 · Received July 8, 2020

    Report

    Report Number
    2028159-2020-00499
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Report Date
    May 19, 2021
    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
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.09., H.3., H.6., AND H.10. THE RESIGHT DOVETAIL WAS RECEIVED AND THE SAMPLE WAS EVALUATED. THE THREADING ON THE LOCKING SCREW OF RETURNED SAMPLE WAS FOUND TO HAVE EXPERIENCED WEAR. THE ROOT CAUSE OF THE REPORTED EVENT MIGHT BE ATTRIBUTED TO CUSTOMER USE/HANDLING. HOWEVER, THIS WAS UNABLE TO BE DETERMINED CONCLUSIVELY WITH THE INFORMATION OBTAINED FOR THIS INVESTIGATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS ABLE TO CONFIRM AND REPLICATE THE REPORTED EVENT. THE NONCONFORMING RESIGHT DOVETAIL WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE SYSTEM MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A BIOMECHANICAL TECHNICIAN REPORTED THAT A LOCKING SCREW ON THE DOVETAIL ONLY TURNS ABOUT THREE-FOURTHS OF A REVOLUTION. UPON FOLLOW UP, THE SCREW BEGAN TO TIGHTEN UP. NO UNEXPECTED OUTCOMES RESULTED. THIS OCCURRED OVER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712620 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1