BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM 2000

    MDR report key: 10174838 · Received June 19, 2020

    Report

    Report Number
    2028159-2020-00452
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    May 21, 2020
    Report Date
    October 29, 2020
    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
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS EXAMINED. THERE WAS NOTHING IN THE SERVICING RECORD (SR) THAT INDICATED THE ABERROMETER READINGS/MEASUREMENT CONTRIBUTED TO THE REPORTED ISSUE. AS SUCH, THE REPORTED ¿MEASUREMENT BEING OFF BY 3.00(D)¿ WAS UNABLE TO BE CONFIRMED. 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 OF THE CUSTOMER REPORTED EVENT THAT THE MEASUREMENTS WERE OFF BY 3 DIOPTERS 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 CLINIC REPORTED, THE INTRAOPERATIVE ABERROMETER WAS THREE DIOPTERS OFF DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SITE DID NOT USE THE MEASUREMENTS PROVIDED AND WENT WITH THEIR PREOPERATIVE PLAN. ADDITIONAL INFORMATION IS REQUESTED. THERE ARE TWO RELATED REPORTS FOR THIS EVENT. THIS REPORT REPRESENTS THE UNIDENTIFIED PATIENT AND AN ADDITIONAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636262 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1