BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA SYSTEM 2000

    MDR report key: 8005601 · Received October 25, 2018

    Report

    Report Number
    2028159-2018-02247
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    September 26, 2018
    Report Date
    February 14, 2019
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    NCF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANY CLINICAL APPLICATIONS SPECIALIST (CAS) REVIEWED THE CALCULATIONS AND IMAGES. THE CAS FOUND THE SURGEON USED TWO DIFFERENT GELS ON THE CORNEA FOR THIS CASE. A REVIEW OF THE CHART NOTED THE SURGEON USED AN ONLINE POST LASIK FORMULA AND CORNEAL TOPOGRAPHY, WHICH WAS VERY DIFFERENT FROM ANOTHER CORNEAL TOPOGRAPHY. THE STAFF NOTED THEY HAD RECEIVED VERY LITTLE TRAINING. THE CAS SPOKE TO THE OFFICE MANAGER IMMEDIATELY TO SET UP AN OFFICIAL FULL TRAINING FOR THE NEW STAFF. THE CAS REVIEWED THE DATA WITH THE SURGEON AND REITERATED NOT USING ANOTHER FORMULA THAT IS NOT COMPATIBLE WITH THE SYSTEM. WHEN THE TOPOGRAPHY KERATOMETRY READINGS WERE REVIEWED THAT THE STAFF ENTERED IN THE SYSTEM, THE DATA WAS 2.00 DIOPTERS OFF FROM ANOTHER KERATOMETER'S READING. THE CAS REVIEWED WITH THE SURGEON THE INCORRECT ENTRIES OF DATA AND THE GELS ON THE CORNEA MAY HAVE CONTRIBUTED TO THE MISSED TARGET. THE SURGEON AGREED AND NOTED HE WILL AVOID USING THE GELS, EVEN THOUGH HE LIKES THEM BECAUSE THEY IMPROVE HIS VIEW AND KEEPS THE CORNEA WET. THE ROOT CAUSE OF THE REPORTED CAN BE ATTRIBUTED TO SURGICAL/CLINICAL FACTORS, AND PATIENT DATA PRE-OPERATIVE DATA ENTRY DISCREPANCIES. BOTH ROOT CAUSES ARE UNRELATED TO DEVICE FUNCTIONALITY. 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. BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORT A -3.00 DIOPTER MISSED TARGET POST INTRAOCULAR LENS (IOL) IMPLANT. IN THE PHYSICIAN'S OPINION, THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. UPON FOLLOW UP, VISION WAS NOT AS WAS EXPECTED. CORNEA WAS CLEAR. REFRACTION WILL BE REPEATED IN A WEEK AND AN IOL EXCHANGE MAY BE PERFORMED IF THE PATIENT DOES NOT WANT GOOD UNCORRECTED VISION FOR READING. ADDITIONAL INFORMATION WAS RECEIVED. SURGEON USED GELS ON THE CORNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848080 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other