BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYSEPT

    MDR report key: 10228186 · Received July 3, 2020

    Report

    Report Number
    3004178847-2020-00012
    Event Type
    Malfunction
    Date Received
    July 3, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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 · 0

    ADDITIONAL INFORMATION: SECTION D10: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D10: RETURNED TO MANUFACTURER ON: 07/02/2019. SECTION H3: DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: ONE KIT OF PRODUCT WAS RETURNED WITH TWO BOTTLES AND TWO OXYCUPS INSIDE. BY THE VISUAL INSPECTION, BOTH OXYCUPS SHOWED MOLD AT THE FILTER OF THE CAP. ONE OF THE TWO RETURNED BOTTLE HAS BEEN USED, CHEMICAL TEST WAS PERFORMED ON THE USED BOTTLE. ALL THE RESULTS ARE WITHIN THE PRODUCT SPECIFICATION. HENCE, NO PRODUCT DEFICIENCY CAN BE CONFIRMED. MANUFACTURING RECORDS REVIEW: REPORTED LOT NUMBER ZE07989 WAS A LABELLED BOTTLE LOT. ITS FILLING LOT ZE07988 AND COMPOUNDING LOT ZE07987 WERE MANUFACTURED IN DEC 2019. ALL 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 DATA WAS TRENDED IN PREVIOUS 12 MONTHS BY THE REPORTED LOT NUMBER: ZE07989; SEARCH RESULT: ONLY THE OBJECTIVE COMPLAINT WAS REPORTED FOR THE SIMILAR ISSUE 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 · 1

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. UNIQUE IDENTIFIER: A COMPLETE UDI# IS UNKNOWN AS LOT# WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS LOT NUMBER WAS NOT PROVIDED. DEVICE MANUFACTURED DATE: UNKNOWN, AS LOT NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED REPORT FROM A CONSUMER STATING THAT A BLACK MOLD-LIKE SUBSTANCE HAS GROWN ON THE FILTER BEHIND THE LID OF HER CONTACT LENS CASE/CUP OF CONSEPT 1-STEP PRODUCT. CONSUMER RINSES HER CASE IN WATER AND LETS IT DRY NATURALLY. SHE SAID THIS HAS OCCURRED SEVERAL TIMES WITHIN ONE MONTH OF BEGINNING USE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692349 OXYSEPT ACCESSORIES LPN JOHNSON & JOHNSON SURGICAL VISION, INC. OXYTC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 SOLUTION LOT ZE07989, TABLETS LOT 84068