BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM 2000

    MDR report key: 10534812 · Received September 15, 2020

    Report

    Report Number
    2028159-2020-00738
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Report Date
    December 17, 2020
    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
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS ABLE TO CONFIRM THE CUSTOMER REPORTED EVENT. THE COMPANY SERVICE REPRESENTATIVE TIGHTENED ALL SCREWS ON THE ABERROMETER DOVETAIL TO RESOLVE THE CUSTOMER REPORTED EVENT. THE COMPANY SERVICE REPRESENTATIVE PERFORMED FIELD VERIFICATION TESTING (FVT) AND VERIFIED THE ALIGNMENT OF THE ABERROMETER TO THE MICROSCOPE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE DOVETAIL AND MOUNTING BRACKET ASSEMBLY ENABLES THE CUSTOMER TO REMOVE AND REPLACE THE ABERROMETER PER THE CUSTOMER¿S DISCRETION. THUS, THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO LOOSE DOVETAIL THAT IS LIKELY THE RESULT OF CUSTOMER USE/HANDLING. HOWEVER, WITH THE INFORMATION PROVIDED FOR THIS INVESTIGATION, THIS IS UNABLE TO BE DETERMINED CONCLUSIVELY. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO LOOSE DOVETAIL. HOW OR WHEN THE DOVETAIL BECAME LOOSE IS UNABLE TO 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 FACILITY REPRESENTATIVE REPORTED THE DOVETAIL ON THE SCOPE SEEMED LOOSE AND REQUESTED IT TO BE CHECKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001088 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1