BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUBBLE CONTACT LENSES

    MDR report key: 11885031 · Received May 25, 2021

    Report

    Report Number
    MW5101536
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    May 22, 2021
    Report Date
    May 22, 2021
    Manufacturer
    ST. SHINE OPTICAL CO., LTD.
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT TOOK LEGAL CONTACT LENS PRESCRIPTION TO HUBBLE, WHO FILLED ILLEGALLY. PROPER CL PARAMETERS AND BRAND WERE NOT FOLLOWED. UNSURE IF PT EVEN GOT CORRECT PRESCRIPTION. THIS HAS CAUSED IRRITATION TO THE LEFT EYE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772826 HUBBLE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL ST. SHINE OPTICAL CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other