BEUDAMED
    FDA Adverse Event Summary report: N

    HUBBLE CONTACT LENSES

    MDR report key: 11664031 · Received April 13, 2021

    Report

    Report Number
    MW5100764
    Date Received
    April 13, 2021
    Date of Event
    March 26, 2021
    Report Date
    April 12, 2021
    Manufacturer
    ST. SHINE OPTICAL CO., LTD.
    Product Code
    LPL
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTS PURCHASING HUBBLE CONTACT LENSES FROM THEIR WEBSITE WITHOUT BEING ASKED FOR ANY PRESCRIPTION IN (B)(6) 2021. NO SIGNIFICANT DAMAGE TO OCULAR HEALTH WAS PRESENT BUT PATIENT ADMITS TO BEING SURPRISED NO PRESCRIPTION WAS NEEDED AND REPORTS POOR COMFORT IN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555714 HUBBLE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL ST. SHINE OPTICAL CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other