BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL-OK LENS

    MDR report key: 17442897 · Received August 1, 2023

    Report

    Report Number
    MW5120477
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    July 22, 2023
    Report Date
    July 30, 2023
    Manufacturer
    C & E GP SPECIALISTS, INC.
    Product Code
    MUW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER APPLYING TO MY SON'S EYE, HE HAD SERIOUS PUFFY EYES IMMEDIATELY THE OTHER DAY. HERE IS THE PRODUCT ORTHOK LENSES HTTPS:// ORTHOKPORTFOLIO.COM/GOV/.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457624 GLOBAL-OK LENS LENS, CONTACT (ORTHOKERATOLOGY) MUW C & E GP SPECIALISTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male Required Intervention