BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYSEPT

    MDR report key: 17056644 · Received June 5, 2023

    Report

    Report Number
    3012236936-2023-01382
    Event Type
    Injury
    Date Received
    June 5, 2023
    Date of Event
    May 9, 2023
    Report Date
    June 2, 2023
    Manufacturer
    AMO(HANGZHOU) CO., LTD.
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION, SECTION A2, AND A5: UNKNOWN/NO INFORMATION. SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN EXPLANTABLE DEVICE. SECTION E1. TELEPHONE NUMBER, (B)(6). SECTION G4, PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE, CONSEPT 1-STEP SOLUTION IS THE SAME AS OXYSEPT SOLUTION WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P850088. SECTION H3-OTHER (81): THE DEVICE HAS NOT RETURNED FOR EVALUATION. THEREFORE, A VISUAL ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    RECEIVED A REPORT FROM A USER INDICATING THAT BOTH SHE AND HER HUSBAND HAD USED THE SAME BOTTLE OF CONCEPT 1 STEP SOLUTION. THE PRODUCT WAS OPENED (B)(6) 2023. THE USER AND HER HUSBAND HAD A STRANGE FEELING IN THEIR EYES AFTER STARTING USE OF THE FIRST BOTTLE OF DISINFECTANT SOLUTION OF THE SECOND PACK ON (B)(6) 2023. HER HUSBAND HAD A WHITE-BLURRED VISION ON (B)(6) 2023 AND VISITED AN EYE CLINIC ON (B)(6) 2023. IRITIS WAS DIAGNOSED AND HE WAS REFERRED TO A (B)(6) HOSPITAL. HE HAD PLANNED TO VISIT THE (B)(6) HOSPITAL ON THE REPORTING DATE OF (B)(6) 2023. HER HUSBAND HAD LOST HIS GOOD EYE SIGHT, BEEN HARD TO SEE AT CLOSE RANGE, AND UNABLE TO SEE TEXTS ON SMARTPHONE'S SCREEN WELL. HE WAS PRESCRIBED MEDICATION BUT DID NOT WAS TO DISCLOSE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288833 OXYSEPT ACCESSORIES, SOFT LENS PRODUCTS LPN AMO(HANGZHOU) CO., LTD. 7167X ZK07712

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention TABLETS UNKNOWN LOT NUMBER.