BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE MOIST

    MDR report key: 15282839 · Received August 23, 2022

    Report

    Report Number
    MW5111674
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    July 1, 2022
    Report Date
    August 20, 2022
    Manufacturer
    JOHNSON AND JOHNSON VISION CARE, INC.
    Product Code
    LPL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USE OF ACUVUE MOIST BRAND CONTACT LENS RESULTED IN EYE REDNESS, EXCESSIVE TEARING AND ITCHINESS THAT REQUIRED 2 ROUNDS OF OPHTHALMIC ANTIBIOTICS (NEOMYCIN/POLYMYXIN/DEXAMETHASONE, THEN TOBRAMYCIN/DEXAMETHASONE) IN MY RIGHT EYE TO CLEAR UP. I USE DIFFERENT STRENGTHS OF CONTACT LENS AND MY LEFT EYE HAD NO ISSUES. LOT # 153562 1403C, EXP DATE: 1/1/2027. EYE GLASSES WERE WORN DURING THIS TIME. RESUMPTION OF CONTACT LENS HAS RESULTED IN SAME ISSUE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346944 ACUVUE MOIST LENSES, SOFT CONTACT, DAILY WEAR LPL JOHNSON AND JOHNSON VISION CARE, INC. 153562 1403C

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other