BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUBBLE

    MDR report key: 14570732 · Received June 1, 2022

    Report

    Report Number
    9617499-2022-00004
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    March 31, 2022
    Report Date
    June 2, 2022
    Manufacturer
    ST. SHINE OPTICAL CO., LTD.
    Product Code
    MVN
    PMA / PMN Number
    K121201
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    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. THE INFORMATION ABOUT PATIENT AND INITIAL REPORTER AS WELL AS OTHER INFORMATION REQUIRED TO SUBMIT WAS NOT 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 THROUGH MEDWATCH REPORT. REPORT NUMBER: MW5108754. THE EVENT DESCRIPTION WAS: "BACTERIAL INFECTION DUE TO SOFT CONTACT LENS WEAR FROM AN IMPROPERLY FIT SOFT CONTACT LENS WHICH WAS NEVER PRESCRIBED TO THE PATIENT. THE PATIENT REPORTS WEARING HUBBLE CONTACTS CONSISTENTLY OVER THE PAST FOUR YEARS. BY HIS REPORT, HE HAS NOT SEEN AN EYE CARE PROVIDER IN OVER FOUR YEARS. THE FELLOW EYE HAS BEEN BLIND FOR DECADES DUE TO AN UNRELATED INJURY. IF HE LOSES VISION DUE TO THIS INFECTION, IT HAS THE POTENTIAL TO SEVERELY AFFECT HIS QUALITY OF LIFE AND ABILITY TO WORK. FDA SAFETY REPORT ID# (B)(4).".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184824 HUBBLE SOFT CONTACT LENS MVN ST. SHINE OPTICAL CO., LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other