BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM 2000

    MDR report key: 7138033 · Received December 21, 2017

    Report

    Report Number
    2028159-2017-04570
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Report Date
    August 27, 2018
    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
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS NOT REPLICATED. THE ABERROMETER WAS SUBSEQUENTLY REPLACED. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. BASED ON QUALITY ASSURANCE ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE SYSTEM WAS FOUND TO MEET SPECIFICATIONS. THEREFORE THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED CONCLUSIVELY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ABERROMETER WAS RECEIVED AT THE FOR EVALUATION. A VISUAL ASSESSMENT OF THE RETURNED SAMPLE REVEALED DISCOLORATION ON THE ABERROMETER COVER. ADDITIONALLY, A GAP WAS NOTED AT THE ABERROMETER NOSE COVER. THE RETURNED SAMPLE WAS CONNECTED TO A CART AND TESTED, AND ALL MEASUREMENTS TAKEN PER MOCK SURGERY PASSED SPECIFICATION. UNRELATED TO THE REPORTED EVENT, THE WIDE FIELD OF VIEW (WFOV) WAS FOUND TO BE OUT OF SPECIFICATION. WHILE THE FOCUS CAMERA ALSO FAILED MANUFACTURING SPECIFICATION, IT PASSED THE PRODUCT SPECIFICATION. AS NO ISSUES WERE IDENTIFIED WITH THE ABERROMETER PROVIDING ACCURATE LENS POWER RECOMMENDATIONS, THE ROOT CAUSE 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 CUSTOMER REPORTED THAT THE SYSTEMS CALCULATIONS WERE OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916181 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other