BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYSEPT

    MDR report key: 18022169 · Received October 27, 2023

    Report

    Report Number
    3012236936-2023-02713
    Event Type
    Injury
    Date Received
    October 27, 2023
    Report Date
    January 9, 2024
    Manufacturer
    PIRAMAL PHARMA LIMITED
    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 D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: DECEMBER 5, 2023. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. THE RETAINED SAMPLE AND RETURNED SAMPLE OF THE COMPLAINT BATCH FOR THE RECEIVED COMPLAINT FOLDER WERE ANALYZED FOR NEUTRALIZATION AND DISSOLUTION TIME, PH, AND CATALASE ACTIVITY; THE RESULTS WERE FOUND WITHIN SPECIFICATION WITH NO ABNORMALITY OBSERVED. THE BATCHES WERE MANUFACTURED AS PER APPROVED BATCH MANUFACTURING RECORD. DISPENSING, GRANULATION, COMPRESSION, FILM COATING, AND DRYING PROCESSES REVEALED THAT ALL THE PARAMETERS WERE WITHIN LIMIT. NO UNUSUAL OBSERVATION NOTED DURING THE REVIEW OF BATCH PACKAGING RECORD. THE ANNUAL PRODUCT QUALITY REVIEW OF SAID PRODUCT ALONG WITH ANALYTICAL DATA OF BATCHES MANUFACTURED FROM 01 JAN 2023 TO DATE OF RECEIPT OF THE COMPLAINT WERE REVIEWED FOR PROCESS CHANGE, MANUFACTURING DEVIATIONS, ANALYTICAL RESULTS, AND STABILITY RESULTS; ALL THE RESULTS WERE WITHIN THE SPECIFICATION LIMIT. THERE WERE NO INCIDENTS/DEVIATIONS OBSERVED DURING THE COMPLAINT BATCH MANUFACTURING. DEVIATION/INCIDENT HISTORY REVIEW FOR THE PAST TWO YEARS DID NOT REVEAL ANY RECORDS THAT CAN LEAD TO SUCH COMPLAINT SITUATION. CONCLUSION: BASED ON THE INVESTIGATION IT CAN BE CONCLUDED THAT, THE COMPLAINT IS NOT GENERATED DUE TO ANY QUALITY ISSUE IN THE COMPLAINT BATCH. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2 AND A4: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION B3 - DATE OF EVENT: DATE UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED SECTION D6A - IMPLANT DATE: DOES NOT APPLY - NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: DOES NOT APPLY - NOT AN IMPLANTABLE DEVICE. SECTION H3 - OTHER (81): MATERIAL 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 WAS MADE TO OBTAIN 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 BY A USER WHO HAD USED CONSEPT 1-STEP (300 ML X 3) FOR THE FIRST TIME THAT HE HAD HAD REDNESS IN HIS EYES EVERY TIME HE HAD WORN HIS CONTACT LENSES TAKEN CARE OF WITH THE PRODUCT. THE CUSTOMER HAD USED THE PRODUCT ACCORDING TO THE INSTRUCTIONS. HE VISITED AN EYE CLINIC AND CONJUNCTIVITIS WAS DIAGNOSED. THE PHYSICIAN PRESCRIBED OFLOXACIN OPHTHALMIC OINTMENT, LEVOFLOXACIN OPHTHALMIC SOLUTION, FLUMETHOLON OPHTHALMIC SUSPENSION. THE CUSTOMER HAS STILL NOT RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE EVENT FOR THE TABLETS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE SOLUTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048900 OXYSEPT ACCESSORIES, SOFT LENS PRODUCTS LPN PIRAMAL PHARMA LIMITED 9081X 98840

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention SOLUTION LOT# ZK06779.