BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFRESH CONTACTS, CONTACT LENS COMFORT DROPS

    MDR report key: 9213850 · Received October 18, 2019

    Report

    Report Number
    MW5090493
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Report Date
    October 16, 2019
    Manufacturer
    ALLERGAN SALES, LLC
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BECAUSE MY CONTACT LENSES WERE BOTHERING ME, I PURCHASED TWO (2) OVER-THE-COUNTER PRODUCTS MADE BY ALLERGAN, INC., (B)(4) U.S.A. REFRESH CONTACTS, CONTACT LENS COMFORT DROPS, 0.4 FL OZ (12 ML) STERILE; AND REFRESH OPTIVE GEL DROPS LUBRICANT EYE GEL, EXTENDED THERAPY 0.33 FL OZ (10 ML) STERILE. HOWEVER, THE REFRESH CONTACTS, CONTACT LENS COMFORT DROPS PACKAGING DOES NOT INCLUDE ANY "DRUG FACTS" ITEMIZATION OF THE PERCENTAGES OF ITS INGREDIENTS (AS DOES THEIR OTHER REFRESH OPTIVE GEL DROPS PRODUCT); THE PACKAGING MERELY LISTS "CONTENTS" OF THE PRODUCT. I WOULD HAVE BETTER DETERMINED THE ORIGIN OF THE DISCHARGE COMING FROM MY EYES THAT RESULTED SEVERAL HOURS AFTER USING BOTH PRODUCTS IF I COULD HAVE KNOWN THE STRENGTH OF THE CONTENTS OF THE REFRESH CONTACTS, CONTACT LENS COMFORT DROPS. REASON FOR USE: CONTACT LENSES WERE IRRITATING AND STICKING TO MY EYES. THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005291 REFRESH CONTACTS, CONTACT LENS COMFORT DROPS ACCESSORIES, SOFT LENS PRODUCTS LPN ALLERGAN SALES, LLC 08743

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other