BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUBBLE

    MDR report key: 14314406 · Received May 7, 2022

    Report

    Report Number
    9617499-2022-00002
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    March 10, 2022
    Report Date
    May 6, 2022
    Manufacturer
    ST. SHINE OPTICAL CO., LTD.
    Product Code
    MVN
    PMA / PMN Number
    K121201
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER IS UNKNOWN AND THE PRODUCTS ARE NOT MADE AVAILABLE FOR EVALUATION AT THIS TIME. OUR DISTRIBUTOR CONTACTED THE INITIAL REPORTER TO OBTAIN THE ADDITIONAL INFORMATION VIA EMAIL AND PHONE, HOWEVER, THERE'S NO ADDITIONAL INFORMATION PROVIDED. NO EVALUATION COULD BE PERFORMED. IF THE ADDITIONAL INFORMATION IS RECEIVED, THE FOLLOW-UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF THE RECEIPT. SUBSEQUENT ACTIONS REGARDING THE FOLLOW-UP REPORT WILL BE TAKEN AND SUBMITTED IN ACCORDANCE WITH 21 CFR 803.10 AND 803.56.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS OBTAINED WHEN SEARCHING THE MAUDE DATABASE ON (B)(6) 2022. REPORT NUMBER: MW5108108. THE EVENT DESCRIPTION WAS: "PATIENT IS USING HUBBLE CONTACT LENSES SINCE 2018 WITH NO UPDATED PRESCRIPTION. PATIENT NOW HAS DAMAGE TO THE CORNEA OF BOTH EYES. HUBBLE HAS BEEN VIOLATING ONLINE SALES OF CONTACT LENSES IN A VARIETY OF WAYS. BILATERAL CORNEAL NEOVASCULARIZATION. FDA SAFETY REPORT ID # (B)(4).".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976501 HUBBLE SOFT CONTACT LENS MVN ST. SHINE OPTICAL CO., LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention