BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOTICA COLOR CONTACT LENSES

    MDR report key: 18798572 · Received February 27, 2024

    Report

    Report Number
    MW5152062
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    February 14, 2024
    Report Date
    February 14, 2024
    Manufacturer
    SOLOTICA INDUSTRIA E COMERCIO LTDA
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEW PATIENT TO MY OFFICE WEARING SOLOTICA COLOR CONTACT LENSES THAT ARE YEARLY REPLACEMENT. PATIENT REPORTING THESE ARE HEALTHY FDA APPROVED CONTACT LENSES. UPON EXAMINATION PATIENT HAD 360-DEGREE NEOVASCULARIZATION OF LIMBUS CORNEA FROM USING CONTACT LENSES ALL DAY DUE TO LACK OF OXYGEN PERMEABILITY TO THE CONTACT LENSES FROM THE LOW DK/T. PATIENT IS UNDER IMPRESSION THAT ITS FDA APPROVED SO IT'S HEALTHY TO USE ALL DAY. THERE IS NOWHERE ON THE WEBSITE THAT SATES HOW MANY HOURS TO WEAR NOR HOW MUCH OXYGEN. SHE ALSO PURCHASED THIS ONLINE WITHOUT AN EYE DOCTOR APPROVAL. HTTPS://WWW.SOLOTICA.COM/.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451673 SOLOTICA COLOR CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL SOLOTICA INDUSTRIA E COMERCIO LTDA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other| R