BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRASOFT TORICXW CONTACT LENSES

    MDR report key: 3983525 · Received August 1, 2014

    Report

    Report Number
    MW5037618
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    May 24, 2014
    Report Date
    July 31, 2014
    Manufacturer
    COOPERVISION
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SEVERE EYE PAIN AFTER WEARING "HYDRASOFT TORICXW" MADE BY COOPERVISION IN (B)(4). I PURCHASED A PAIR OF HYDRASOFT TORICXW CONTACT LENSES THROUGH (B)(4) IN (B)(6) 2014. ON (B)(6) 2014, I STARTED WEARING THIS PAIR, WITHIN 3 HOURS AFTER PUT ON THE LENSES, I STARTED TO FEEL SOME DISCOMFORT ON MY LEFT EYE, THEN THE LEFT EYE PRODUCED LOTS OF TEARS AND I HAD TO USE PAPER TISSUE TO WIPE THEM OFF. BY THE TIME WHEN I WAS DRIVING HOME, MY LEFT EYE CONDITION PROGRESSED TO HAVE SEVERE PAIN. AFTER I GOT HOME, I IMMEDIATELY REMOVED THE LENSES FROM MY EYES AND THE INTENSE PAIN LASTED ANOTHER 2 HOURS BEFORE IT DISAPPEARED GRADUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451490 HYDRASOFT TORICXW CONTACT LENSES CONTACT LENS LPN COOPERVISION TORICXW "U146UD"
    451491 HYDRASOFT TORICXW CONTACT LENSES CONTACT LENS LPN COOPERVISION TORICXW "U146UA"

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR