BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUBBLE

    MDR report key: 14049854 · Received April 8, 2022

    Report

    Report Number
    9617499-2022-00001
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    January 19, 2022
    Report Date
    April 8, 2022
    Manufacturer
    ST. SHINE OPTICAL CO., LTD.
    Product Code
    MVN
    PMA / PMN Number
    K121201
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 AND MAUDE DATABASE ON MAR. 11, 2022. REPORT NUMBER: MW5107278. THE EVENT DESCRIPTION WAS: "PATIENT ORDERED CONTACTS OFF OF (B)(6) TO WEAR AND THIS LED TO OCULAR INFLAMMATION WHICH COULD LEAD TO SCARRING AND VISION LOSS. EYE EXAM SHOWED SEVERE CORNEAL AND CONJUNCTIVAL INFLAMMATION FROM CONTACT LENS USE. FDA SAFETY REPORT ID # (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328097 HUBBLE SOFT CONTACT LENS MVN ST. SHINE OPTICAL CO., LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other