BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOTICA HIDROCOR CONTACT LENS

    MDR report key: 11817371 · Received May 12, 2021

    Report

    Report Number
    MW5101324
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    May 8, 2021
    Report Date
    May 11, 2021
    Manufacturer
    SOLOTICA INDUSTRIA E COMERCIO LTDA
    Product Code
    HQD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT PRESENTED WEARING CONTACT LENSES SOLD ILLEGALLY ONLINE. THE PRODUCT BRAND IS SOLOTICA, THE PRODUCT HIDROCOR. BECAUSE THIS PRODUCT WAS NOT PROPERLY EVALUATED BEFORE IT WAS PRESCRIBED, SHE NOW HAS A PERMANENT CORNEAL SCAR AND PERMANENT CORNEAL NEOVASCULARIZATION AND PANNUS. WHEN VISITING THE WEBSITE, ANYONE IS ALLOWED TO ORDER ANY PRESCRIPTION OR COLOR, WITHOUT ENTERING A PROPER, LEGAL PRESCRIPTION FROM A LICENSED PRACTITIONER. THE PRODUCT IS MADE IN (B)(4), AND SHIPPED FROM EITHER (B)(4). IT IS AN FDA APPROVED MEDICAL DEVICE, HOWEVER, IN THE APPROVAL LETTER FROM 2016, THE FDA CLEARLY SPECIFIES THE COMPANY HAS TO FOLLOW RULES AND REGULATIONS CONCERNING THIS MEDICAL DEVICE. THEY CLEARLY HAVE NOT, AS ANY CONTACT LENS PRESCRIBED HAS TO BE EVALUATED AND FIT BY A LICENSED PRACTITIONER, LEADING TO A VALID CONTACT LENS PRESCRIPTION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706819 SOLOTICA HIDROCOR CONTACT LENS LENS, CONTACT (OTHER MATERIAL) - DAILY HQD SOLOTICA INDUSTRIA E COMERCIO LTDA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other