BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM 2000

    MDR report key: 8727406 · Received June 24, 2019

    Report

    Report Number
    2028159-2019-01169
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    May 29, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS CONFIRMED. THE COMPANY REPRESENTATIVE TIGHTENED THE TWO SCREWS HOLDING THE LOCKING HANDLE TO THE DOVETAIL. THE COMPANY REPRESENTATIVE ALSO ADMINISTERED LOCTITE ON TO THE THREADS TO PREVENT IT FROM COMING LOOSE AGAIN. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY ATTRIBUTED TO CUSTOMER USE/HANDLING. HOWEVER, THIS IS UNABLE TO BE DETERMINED CONCLUSIVELY WITH THE INFORMATION OBTAINED FOR THIS INVESTIGATION. 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 CUSTOMER REPORTED THAT THE DOVETAIL HANDLE CAME OFF DUE TO LOOSE SCREWS. THE CUSTOMER WAS ABLE TO TIGHTEN THE SCREWS ENOUGH TO USE THE HANDLE TO LOCK DOWN THE ABERROMETER. THERE WAS NO PATIENT INVOLVEMENT AS THE PROCEDURE HAD NOT BEGUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523170 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1