BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA SYSTEM 2000

    MDR report key: 8018898 · Received October 30, 2018

    Report

    Report Number
    2028159-2018-02270
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    September 25, 2018
    Report Date
    March 5, 2019
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO PATIENT FACTORS UNRELATED TO THE FUNCTIONALITY OF THE DEVICE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN UNEXPECTED OUTCOME POST INTRAOPERATIVE ABERROMETRY. THE TARGET WAS PLANO BUT THE PATIENT ENDED UP A -5.00. THE PATIENT IS NOT HAPPY. THE SYSTEMS RECOMMENDED POWER WAS THE SAME AS THE PREOPERATIVE CALCULATIONS. THE PATIENT WAS NOTED TO HAVE FLAT KERATOMETRY READINGS AND A LONG EYE. THE SURGEON IS PLANNING AN INTRAOCULAR LENS EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860037 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other