BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA SYSTEM 2000

    MDR report key: 7959881 · Received October 12, 2018

    Report

    Report Number
    2028159-2018-02137
    Event Type
    Injury
    Date Received
    October 12, 2018
    Report Date
    December 11, 2018
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    NCF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED EVENT. NO ISSUES WERE IDENTIFIED WITH THE SYSTEM. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE SYSTEM WAS FOUND TO MEET SPECIFICATIONS; 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED FALSE READINGS DURING INTRAOPERATIVE ABERROMETRY. THE SITE REPORTS THIS HAS RESULTED IN TEN EXPLANTS DUE TO UNEXPECTED OUTCOMES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800099 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention