BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA

    MDR report key: 9840160 · Received March 16, 2020

    Report

    Report Number
    MW5093775
    Event Type
    Injury
    Date Received
    March 16, 2020
    Date of Event
    January 28, 2020
    Report Date
    March 12, 2020
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    NCF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WRONG LENS MEASUREMENT; NEAR MISS EVENT RELATED TO ADJUSTMENT WITH ORA PRODUCT - NO INJURY TO PT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301587 ORA ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LLC ORA SN6AT6

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR