BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTI FREE PURE MOIST CONTACT LENS SOLUTION

    MDR report key: 16294973 · Received February 2, 2023

    Report

    Report Number
    MW5114662
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Report Date
    January 31, 2023
    Manufacturer
    ALCON RESEARCH, LLC.
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THERE IS A STRONG MOLD SMELL IN BOTTLES OF OPTI FREE PURE MOIST CONTACT LENS SOLUTION. PURCHASED A TWO PACK AT BJ'S AND THOUGHT IT WAS A FLUKE ISSUE FROM THE SUPPLIER. BOUGHT ANOTHER TWO PACK AT CVS PHARMACY AND THE SAME STRONG, MOLD SMELL IS PRESENT. RULED OUT EVERYTHING AND IT IS THE SOLUTION. SMELL COMES FROM THE BOTTLE AND IS POTENT WHEN POURED OUT, IN THE CONTACT CASE, AND ON THE HANDS. MY EYES FEEL EXCESSIVELY DRY AND STRAINED. ALSO OCCASIONAL BURNING SENSATION OCCURS. SWITCHED TO ANOTHER BRAND TO AVOID DAMAGE. THIS NEEDS TO BE ADDRESSED IMMEDIATELY AS I FOUND MANY DISCUSSING THE ISSUE ONLINE AND HAVING THE SAME CONCERNS. A RISK TO HEALTH OF THE EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227291 OPTI FREE PURE MOIST CONTACT LENS SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LLC. 1193H
    1227292 OPTI FREE PURE MOIST CONTACT LENS SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LLC. 1193H
    1227293 OPTI FREE PURE MOIST CONTACT LENS SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LLC. 1194X
    1227294 OPTI FREE PURE MOIST CONTACT LENS SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LLC. 1194X

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female