BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYSEPT

    MDR report key: 19698080 · Received July 8, 2024

    Report

    Report Number
    3012236936-2024-000188
    Event Type
    Injury
    Date Received
    July 8, 2024
    Report Date
    September 19, 2024
    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

    CORRECTED DATA: UPON FURTHER REVIEW OF THE REPORTED EVENT, IT HAS BEEN DETERMINED THAT THE COMPLAINT DOES NOT MEET THE REPORTABILITY CRITERIA FOR A REPORTABLE SERIOUS INJURY OR MALFUNCTION. THE SYMPTOMS REPORTED (REDNESS IN EYES AND POSSIBLE ALLERGIC REACTION) ARE NOT SERIOUS IN NATURE AND ALTHOUGH MEDICATIONS WERE GIVEN, THEY WERE NOT TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR TO PREVENT PERMANENT DAMAGE TO A BODY STRUCTURE BUT WERE INTENDED TO MITIGATE SYMPTOMS. THEREFORE, THE INITIAL MDR SHOULD NOT HAVE BEEN SUBMITTED. NO FURTHER INFORMATION WILL BE PROVIDED UNDER MDR 3012236936-2024-0001888. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6A - IMPLANT DATE: NOT APPLICABLE, AS THE PRODUCT IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS THE PRODUCT IS NOT AN IMPLANTABLE DEVICE. SECTION E1 - TELEPHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE END-USER EXPERIENCED REDNESSS IN THEIR EYES AFTER USING OXYSEPT 1-STEP PRODUCT. THE END-USER VISITED AN EYE CLINIC AND WAS TOLD BY THE PHYSICIAN THAT IT COULD BE AN ALLERGIC REACTION. ALLEGION AND HYALEIN WERE PRESCRIBED, AND THEY HAVE RECOVERED. IT WAS INDICATED THAT THE END-USER HAD EXCHANGED THE PRODUCT TWICE DUE TO A MOLDY CASE WHEN THE CONTAINER WAS RINSED WITH ANOTHER MANUFACTURER'S SOLUTION. NO FURTHER INFORMATION WAS PROVIDED. THE PRODUCT CONSISTS OF BOTH THE SOLUTION AND NEUTRALIZING TABLETS. THIS REPORT IS FOR THE SOLUTION. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210403 OXYSEPT ACCESSORIES, SOFT LENS PRODUCTS LPN AMO(HANGZHOU) CO., LTD. 7167X ZM05997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention NEUTRALIZING TABLETS, TABLET LOT# 07605.