BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE PURE MOIST

    MDR report key: 14266922 · Received May 2, 2022

    Report

    Report Number
    MW5109470
    Event Type
    Injury
    Date Received
    May 2, 2022
    Date of Event
    October 20, 2021
    Report Date
    April 29, 2022
    Manufacturer
    ALCON RESEARCH, LLC.
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER ALCON REPLACED OPTI-FREE REPLENISH WITH PURE MOIST CONTACT LENS SOLUTION, I BEGAN EXPERIENCING SEVERE DERMATITIS AROUND BOTH EYES THAT TOOK MONTHS TO DIAGNOSE AND IS ONLY NOW BEGINNING TO RESOLVE, BUT I CAN NO LONGER USE ANY CONTACT LENS SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218644 OPTI-FREE PURE MOIST ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LLC. 10NM3

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female