BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSEPT 1-STEP

    MDR report key: 15473325 · Received September 23, 2022

    Report

    Report Number
    3012236936-2022-02374
    Event Type
    Injury
    Date Received
    September 23, 2022
    Report Date
    November 10, 2022
    Manufacturer
    AMO(HANGZHOU) CO., LTD.
    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

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: SEP 20, 2022 SECTION H3: EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. PRODUCT CHEMICAL TEST WAS CONDUCTED ON THE RETURNED SAMPLE, ALL THE TESTED ITEMS MET PRODUCT SPECIFICATION, NO PRODUCT DEFICIENCY WAS CONFIRMED. 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

    PATIENT REPORTED EXPERIENCING RED EYES WITHOUT IRRITATION AFTER USING CONCEPT 1-STEP SOLUTION. THE EVENT OCCURRED TWO WEEKS AGO FROM DATE (B)(6) 2022. THE PATIENT PURCHASED 2 SETS OF CONSEPT 1-STEP (300ML X 3. EACH SET HAS 3 BOTTLES). PURCHASE WAS MADE TWO MONTHS PRIOR IN JUNE (ABOUT MIDDLE OF (B)(6) 2022) AND OPENED IN JULY (AROUND MIDDLE OR LATE (B)(6) 2022). THE NAME OF THE CONTACT LENSES IS UNKNOWN. AFTER USING THE FIRST BOTTLE OF CONSEPT 1-STEP, BOTH OF HIS EYES TURNED RED REPEATEDLY WITHOUT IRRITATION. HE RINSED HIS CONTACT LENSES WITH CONCEPT RINSING SOLUTION, BUT HIS EYES REMAINED RED. HIS CONTACT LENS CASE WAS NOT DAMAGED OR CRACKED. HE STOPPED USING HIS CONTACT LENSES AND USED EYE DROPS FOR TWO WEEKS. HE RESUMED USING HIS CONTACT LENSES ON THE DAY OF THIS CALL, BUT HIS EYES TURNED SLIGHTLY RED AGAIN. PATIENT SOUGHT MEDICAL ATTENTION AND HIS DOCTOR¿S DIAGNOSIS WAS CONJUNCTIVITIS (ALLERGIC SYMPTOM). TWO KINDS OF EYE DROPS WERE PRESCRIBED. ONE WAS ANTIBIOTIC, AND THE OTHER A DECONGESTANT (NAMES ARE UNKNOWN). ALSO PRESCRIBED WAS LEVOFLOXACIN OPHTHALMIC SOLUTION 0.5% AND PRANOPROFEN OPHTHALMIC SOLUTION 0.1%. THROUGH FOLLOW-UP THE PATIENT REPORTED HE HAD RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE DISINFECTANT SOLUTION IN USE FOR THIS CASE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE NEUTRALIZING TABLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2727911 CONSEPT 1-STEP ACCESSORIES, SOFT LENS PRODUCTS LPN AMO(HANGZHOU) CO., LTD. 7167X ZJ07299

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention NEUTRALIZING TABLETS