BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TTDEYE COLOR CONTACT LENES

    MDR report key: 25241315 · Received May 20, 2026

    Report

    Report Number
    MW5188519
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    May 17, 2026
    Report Date
    May 18, 2026
    Manufacturer
    SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 06/12/2026 FOR REPORT MW5188519 TO UPDATE MANUFACTURER.

    Description of Event or Problem · 0

    YESTERDAY/SUNDAY PUT COLOR CONTACT LENSES ON EYES. TOOK LENSES OUT OF BLISTER PACKS. MID-DAY OCULUS SINISTER (OS) BLURRY VISION WITH AND WITHOUT CONTACT LENS WEAR. TODAY/MONDAY ONLY OS STILL SORE, WATERY, FOREIGN BODY SENSATION. SEES FLARE WHEN LOOKS AT LIGHTS. PURCHASED COLOR CONTACT LENSES ON LINE WITHOUT A PRESCRIPTION. TTDEYE BRAND GLACIER BLUE, 38%M POLYMACON, BC 8.4 MM, DIA 14.2 MM. RECEIVED SPHERE POWERS CONTACTS, HOWEVER, HAS SIGNIFICANT ASTIGMATISM IN EYEGLASSES. USING OPTI-FREE REPLENISH TARGET BRAND SOLUTION. BEFORE ALCON BRAND OPTI-FREE REPLENISH MPS. SLIT-LAMP EXAMINATION OS EXTENSION CORNEAL PUNCTATE FLUORESCEIN STAINING, THROUGHOUT CENTRAL TO MID-PERIPHERAL AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509669 TTDEYE COLOR CONTACT LENES LENSES, SOFT CONTACT, DAILY WEAR LPL SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1