BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM 2000

    MDR report key: 7930134 · Received October 3, 2018

    Report

    Report Number
    2028159-2018-02077
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Report Date
    January 4, 2019
    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
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PREVIOUS INFORMATION SENT "MA" WAS INCORRECT. THERE IS NO OTHER REMEDIAL ACTION FOR THIS FILE. ADDITIONAL INFORMATION PROVIDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A COMPANY REPRESENTATIVE PERFORMED AN ON-SITE ASSESSMENT AND REPLACED THE PROCESSOR TO RESOLVE THE REPORTED ISSUE OF THE SYSTEM POWERING ON. HOWEVER, THERE WAS NO INDICATION OF READINGS/MEASUREMENT ISSUES WITH THE ABERROMETER, AND SERVICING WAS NOT PERFORMED ON THE ABERROMETER. THE SYSTEM WAS THEN TESTED AND FOUND TO MEET COMPANY SPECIFICATIONS. AS THE ABERROMETER WAS FOUND TO MEET SPECIFICATION, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD SERVICE ENGINEER (FSE) STATING WHILE TRYING TO START TESTING, THE CART APPARENTLY WAS REGISTERED TO ANOTHER ACCOUNT. THE ORIGINAL DEVICE HAD A POWER PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.

    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. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED FLICKERING AND INCORRECT READINGS WITH THE INTRAOPERATIVE ABERROMETER DURING CATARACT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773677 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1