BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE DOUBLE MOIST

    MDR report key: 10369957 · Received August 5, 2020

    Report

    Report Number
    3004178847-2020-00017
    Event Type
    Injury
    Date Received
    August 5, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LPN
    PMA / PMN Number
    K030092
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D10: DEVICE AVAILABLE FOR EVALUATION: YES; SECTION D10: RETURNED TO MANUFACTURER ON: 8/14/2020; SECTION H3: DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. CHEMICAL TEST WAS PERFORMED TO THE RETURNED PRODUCT. ALL THE TESTING RESULTS WERE WITHIN THE PRODUCT SPECIFICATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORDS REVIEW: COMPLAINT DATA WAS TRENDED IN PREVIOUS 12 MONTHS BY THE REPORTED LOT NUMBER: ZE04796. THE SEARCH RESULTS SHOWED ONLY THE OBJECTIVE COMPLAINT WAS REPORTED IN PREVIOUS 12 MONTHS. CONCLUSION: BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY COULD BE DETERMINED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: EXACT DATE UNKNOWN. BEST ESTIMATE IS DURING (B)(6) 2020. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CONSUMER REPORTED HER EYES ITCHED AFTER USING COMPLETE DOUBLE MOIST MULTIPURPOSE SOLUTION. SYMPTOM OF ITCH WAS FIRST EXPERIENCED ABOUT ONE MONTH AGO, AND THE CONSUMER VISITED AN EYE CLINIC ABOUT TWO WEEKS LATER. MEDICATIONS WERE PRESCRIBED, ODOMEL OPHTHALMIC SUSPENSION, ALESION OPHTHALMIC SOLUTION 0.05% TO ADDRESS HER SYMPTOM. THE DOCTOR DID NOT PROVIDE A DIAGNOSIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833294 COMPLETE DOUBLE MOIST SOLUTIONS LPN JOHNSON & JOHNSON SURGICAL VISION, INC. 08941X ZE04796

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention