BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM 2000

    MDR report key: 10700541 · Received October 19, 2020

    Report

    Report Number
    2028159-2020-00846
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Report Date
    January 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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS NOT REPLICATED. THERE WAS NO EVIDENCE OF DEVICE NONCONFORMITY. HOWEVER, UNRELATED TO THE REPORTED EVENT, THE ABERROMETER WAS REPLACED AS A PREVENTIVE MEASURE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. THE MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE FOR THE ¿DOVETAIL ALIGNMENT SET SCREW ISSUE¿ COULD NOT BE DETERMINED CONCLUSIVELY. THERE IS NO EVIDENCE OF DEVICE NONCONFORMITY. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE ¿READING/MEASUREMENT ISSUE¿ COULD NOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    NEW INFORMATION WAS RECEIVED. THE SCREW THEY FOUND DID NOT COME OUT OF THE ABERROMETER. THEY JUST FOUND IT ON THE FLOOR AND KEPT IT IN CASE.

    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 ABERROMETER KEPT STATING MEASUREMENTS WERE NOT ACCEPTABLE IN SEVERAL CASES. A NURSE INDICATED THAT A SCREW CAME OUT OF THE ABERROMETER. A COMPANY REPRESENTATIVE NOTED THAT THE PICTURE LOOKED LIKE AN ALIGNMENT SET SCREW. VERIFICATION VALUES LOOKED GOOD BUT WAS UNABLE TO VERIFY ON CAMERA ALIGNMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167358 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 ORA VERIFEYE SURG CART.