BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM 2000

    MDR report key: 11786200 · Received May 6, 2021

    Report

    Report Number
    2028159-2021-00466
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Report Date
    September 2, 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
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS CONFIRMED AND REPLICATED. THE COMPANY REPRESENTATIVE REALIGNED AND TIGHTENED THE DOVETAIL TO RESOLVE THE ISSUE. 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 REPORTED EVENT COULD BE ATTRIBUTED TO INTERNAL- WEAR/RELIABILITY. 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 COMPANY REPRESENTATIVE REPORTED DOVETAIL AT ABERROMETER WAS LOOSE. ADDITIONAL INFORMATION WAS RECEIVED. COMPANY REPRESENTATIVE NOTED SEEING SOMEONE AT THE SITE STRUGGLING TO REMOVE AND NOTED THAT IT MOVED A LOT. IT IS UNKNOWN HOW LONG DOVETAIL HAS BEEN THIS WAY. NO PATIENT IMPACT OR STAFF IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678971 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 ORA SYSTEM WITH VERIFEYE MESSAGING, CART