BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSEPT 1-STEP

    MDR report key: 13464074 · Received February 4, 2022

    Report

    Report Number
    3012236936-2022-00204
    Event Type
    Injury
    Date Received
    February 4, 2022
    Date of Event
    January 2, 2022
    Report Date
    May 9, 2022
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    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

    EXPIRATION DATE: THE EXPIRATION DATE IS DECEMBER 2022. UNIQUE IDENTIFIER (UDI) NUMBER: UDI HAS NOT BEEN SUPPLIED BY THE EXTERNAL MANUFACTURER. DEVICE MANUFACTURE DATE: THE MANUFACTURE DATE IS JANUARY 2021. DEVICE HAS NOT RETURNED FOR EVALUATION. THEREFORE, A VISUAL ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: APR 9, 2022. SECTION H3: EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE RETAIN AND RETURN SAMPLE WERE ANALYZED. THE SAMPLES COMPLY TO SPECIFICATIONS. RESULTS OF RETAIN SAMPLE AND RETURN SAMPLE FOUND COMPARABLE, NO ABNORMALITY OBSERVED. A PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    CONSUMER REPORTED THAT SHE EXPERIENCED IRRITATION IN HER RIGHT EYE WHEN WEARING HER CONTACT LENSES AFTER TAKING CARE OF THEM WITH CONSEPT 1-STEP SOLUTION. REPORTEDLY, THE PRODUCT WAS USED PROPERLY. THE CONTACTS LENSES USED WERE ACUVUE OASYS (BI-WEEKLY). THE BOTTLE WAS NEWLY OPENED AND SO WERE THE CONTACTS, OPENED (B)(6) 2022, AND USED. THE NEXT MORNING (B)(6) THE CONSUMER AGAIN EXPERIENCED IRRITATION WHEN WEARING THE CONTACT LENS. CONSUMER SOUGHT MEDICAL ATTENTION AT AN EYE CLINIC. THE DOCTOR SAID HER CORNEA HAD SMALL SCRATCHES, BUT THE CAUSE WAS UNKNOWN. SHE WAS PRESCRIBED TEARBALANCE OPHTHALMIC SOLUTION 0.1%, AND GATIFLO OPHTHALMIC SOLUTION 0.3%, AND WORE EYEGLASSES. THE SYMPTOMS SUBSIDED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE NEUTRALIZING TABLETS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE DISINFECTING SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124907 CONSEPT 1-STEP ACCESSORIES, SOFT LENS PRODUCTS LPN JOHNSON & JOHNSON SURGICAL VISION, INC. 9081X 90996

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention SOLUTION LOT # ZJ05556, ACUVUE OASYS CONTACT LENS