BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFREE PURE MOIST CONTACT SOLUTION

    MDR report key: 16486078 · Received March 3, 2023

    Report

    Report Number
    MW5115413
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Report Date
    March 1, 2023
    Manufacturer
    ALCON RESEARCH, LLC.
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CONTACT SOLUTION HAS A MOLDY SMELL. MULTIPLE BOTTLES FROM SAME LOT. REFERENCE REPORTS MW5115411, MW5115412, MW5115414.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736314 OPTIFREE PURE MOIST CONTACT SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LLC. 118Y4

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female