BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPPERVISION CLARITI 1 DAY

    MDR report key: 16664676 · Received March 31, 2023

    Report

    Report Number
    MW5116227
    Event Type
    Injury
    Date Received
    March 31, 2023
    Date of Event
    March 15, 2023
    Report Date
    March 29, 2023
    Manufacturer
    COPPERVISION
    Product Code
    LPL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BATCH OF COPPERVISION CLARITI 1 DAY LENSES APPEAR TO HAVE CLOUDY MATERIAL IN THE LENS SOLUTION, AFTER WEARING THE EYE IS PRODUCING PUSS, IRRITATION, REDNESS, AND FEELING OF SUPERFICIAL MATERIAL IN EYE. THE LENS ITSELF IS CONTAINED IN SINGLE USE PEEL OFF CASES BUT THERE IS SOME DIFFERENCE FROM THIS BATCH AND ANOTHER PRESCRIPTION STRENGTH. LOT#(10):246376201680088077, BAR CODE # (B)(4), MADE IN CR, EXP DATE:(17) :2026-04-30. PRESCRIPTION: BC 8.6, DIA 14.1, PWR - 2.00, BOX OF 30 COUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250957 COPPERVISION CLARITI 1 DAY LENSES, SOFT CONTACT, DAILY WEAR LPL COPPERVISION 2426376201680080077

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other