BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISIGHT (OMAFILCON A)

    MDR report key: 21904831 · Received April 24, 2025

    Report

    Report Number
    3003981983-2025-00003
    Event Type
    Injury
    Date Received
    April 24, 2025
    Date of Event
    October 7, 2024
    Report Date
    April 24, 2025
    Manufacturer
    COOPERVISION MANUFACTURING, LTD
    Product Code
    QIT
    UDI-DI
    96126LENS143LN
    PMA / PMN Number
    P180035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE REPORTED DETAILS OF THE EVENT, THE PATIENT HAS FAILED TO FOLLOW THE DEVICES INDICATIONS AND INSTRUCTIONS FOR USE. THIS IS A DAILY DISPOSABLE CONTACT LENSES WHICH IS TO BE WORN LESS THAN 24 HOURS, WHILE AWAKE, AND DISCARDED ON REMOVAL. AFTER INSTILLING THE LENS ON 07 OCTOBER, THAT PATIENT CONTINUED TO WEAR OVERNIGHT NIGHT, WHILE SLEEPING, AND INTO THE FOLLOWING DAY BEFORE REMOVING. THIS MAY BE CONSIDERED A CAUSAL OR CONTRIBUTORY FACTOR TO THE EVENT. NO DEVICE SAMPLE WAS RETURNED FOR MANUFACTURER ANALYSIS. A LOT NUMBER WAS PROVIDED FOR THE DEVICE ALLEGED TO BE INVOLVED IN THE INCIDENT. LOT HISTORY, DEVICE HISTORY, STERILIZATION RECORDS, AND TREND REPORTING WERE REVIEWED. NO ISSUES OR NONCONFORMANCE'S WERE FOUND AND NO TRENDS WERE IDENTIFIED. NO ROOT CAUSE COULD BE ESTABLISHED. NO DIRECT CAUSAL RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE PATIENT HAD SLEPT IN THEIR CONTACT LENSES THE EVENING OF 07 OCTOBER 2024 AND CONTINUED USE OF THE SAME LENS ON 08 OCTOBER. THE PATIENT REPORTS THEY EXPERIENCED LIGHT SENSITIVITY, REDNESS, AND WATERING OF THE LEFT (OS) EYE WITH PAIN AND SWELLING ON 08 OCTOBER. THE PATIENT SELF-TREATED WITH AN UNSPECIFIED EYE DROP, EYE FLUSH, AND WARM COMPRESS. WHILE SYMPTOMS HAD IMPROVED, THE PATIENT CONTINUED TO EXPERIENCE REDNESS AND IRRITATION AND WAS SEEN FOR MEDICAL CARE ON (B)(6) 2024. EXAM SHOWED MILD SCATTERED PUNCTATE EPITHELIAL EROSION (PEE), MILD CONJUNCTIVAL INJECTION, MILD SUSPECTED CORNEAL ABRASION, AND +1 ANTERIOR CHAMBER CELLS OF THE LEFT EYE. THE NOTED CORNEAL ABRASION IS INDICATED AS SUSPECTED AND/OR SUBSEQUENT ENCOUNTER AS IT WAS SHOWING SIGNS OF HEALING AT THE TIME OF THE INITIAL VISIT. THE TREATING PHYSICIAN ALSO NOTES SECONDARY DIAGNOSIS OF SUSPECTED CONTACT LENS ASSOCIATED KERATITIS AND IRITIS RELATED TO THE SIGNIFICANT ANTERIOR CHAMBER REACTION. THE PATIENT WAS PRESCRIBED MAXITROL 0.1% DROPS TO BE INSTILLED TWICE DAILY, INSTRUCTED TO TEMPORARILY DISCONTINUE LENS USE AND TO RETURN TO CARE IN 5 DAYS. PATIENT WAS SEEN FOR FOLLOW-UP ON (B)(6) AND REPORTED IMPROVEMENT IN THEIR CONDITION. EXAM SHOWED A FEW REMAINING PEE, CONJUNCTIVAL INJECTION AND ANTERIOR CHAMBER CELLS HAVE RESOLVED AND SUSPECTED KERATITIS OR ABRASION EVENT IS NOW HEALED. PATIENT INSTRUCTED TO DISCONTINUE MAXITROL BUT REMAIN OUT O FLENSES FOR ONE ADDITIONAL WEEK. BASED ON THE DIAGNOSIS FOR IRITIS AND THE POTENTIAL THAT THE MEDICATIONS PRESCRIBED WERE DONE SO TO PREVENT OR PRECLUDE SERIOUS OR PERMANENT INJURY TO THE EYE FUNCTION OR STRUCTURE, THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289492 MISIGHT (OMAFILCON A) MISIGHT (OMAFILCON A) QIT COOPERVISION MANUFACTURING, LTD 96126LENS143LN

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female Other