BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYSEPT

    MDR report key: 9243475 · Received October 28, 2019

    Report

    Report Number
    3004178847-2019-00012
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    September 26, 2019
    Report Date
    November 6, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION YES, RETURNED TO MANUFACTURER ON (B)(6) 2019 . DEVICE RETURNED TO MANUFACTURER YES. PRODUCT EVALUATION: ONE LENS CASE WAS RETURNED. THE LENS CASE WAS DRY AND CRACKED, SOLUTION MAY LEAK FROM IT. THERE WAS BLACK MOLD ON THE MEMBRANE OF THE CAP. NO BOTTLE WAS RETURNED, SO THE TEST TO SOLUTION WAS NOT AVAILABLE. WITHOUT THE PRODUCT TEST, IT CANNOT BE CONFIRMED IF ANY PRODUCT FAILURE TO SOLUTION THAT CUSTOMER USED. MANUFACTURING RECORD REVIEW: REPORTED LOT ZE04472 WAS A KIT LOT NUMBER, ITS FILLING LOT ZD07454 AND COMPOUNDING LOT ZD07453 WERE MANUFACTURED IN NOV 2018. THE RECORDS FOR PRODUCTION PROCESS WERE FOUND TO BE ACCEPTABLE, ALL TESTING ITEMS WERE COMPLETED AND MET SPECIFICATIONS, INCLUDING INCOMING CHEMICAL MATERIALS TESTING, PRIMARY MATERIALS INSPECTION, PRODUCT PHYSICAL APPEARANCE INSPECTION, BULK AND FINISHED PRODUCT CHEMICAL TESTING AND MICROBIAL TESTING, STERILIZATION RECORDS, ENVIRONMENT MONITORING AND WATER SYSTEM MONITORING. THERE WAS NO NON-CONFORMANCE RELATED TO THIS COMPLAINT. IN CONCLUSION, REPORTED LOT WAS DEEMED ACCEPTABLE FOR RELEASE COMPLAINT OCCURRENCES PER LOT/BATCH: COMPLAINT DATA WAS TRENDED IN PREVIOUS 12 MONTHS BY THE REPORTED LOT NUMBER: ZE04472; AS SEARCH OF COMPLAINTS REVEALED ONLY THE OBJECTIVE COMPLAINT WAS REPORTED FOR THE SAME LOT. CONCLUSION: BASED ON BATCH RECORD REVIEW, PRODUCT EVALUATION AND HISTORICAL COMPLAINT REVIEW, THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. AT THE TIME OF THIS REPORT 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

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED SECTION. (B)(6). ALTERNATIVE REPORT IDENTIFICATION NUMBER: (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN USING OXYSEPT FOR A NUMBER OF YEARS WITHOUT ANY ISSUES. HOWEVER, RECENTLY THEY HAVE NOTICED MILDEW IN THEIR LENS CASE. THEY ARE EXTREMELY COMPLIANT AND ALWAYS FOLLOW THE INSTRUCTIONS. NO PATIENT INVOLVEMENT ISSUES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038959 OXYSEPT ACCESSORIES LPN JOHNSON & JOHNSON SURGICAL VISION, INC. OXYTC ZE04472

    Patients

    Seq Age Sex Outcome Treatment
    1 OXYSEPT COMFORT NEUTRALIZING SOLUTION AND TABLETS