BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSEPT 1 STEP

    MDR report key: 12163560 · Received July 13, 2021

    Report

    Report Number
    3004178847-2021-07009
    Event Type
    Injury
    Date Received
    July 13, 2021
    Report Date
    September 12, 2022
    Manufacturer
    AMO(HANGZHOU) CO., LTD.
    Product Code
    LPN
    UDI-DI
    24987617003450
    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: JULY 19, 2021. SECTION H3: EVALUATED BY MANUFACTURER: YES . ADDITIONAL INFORMATION: DEVICE EVALUATION: CHEMICAL TEST WAS CONDUCTED TO THE RETURNED SAMPLE, ALL THE TESTED ITEMS MET THE PRODUCT SPECIFICATION, NO PRODUCT DEFICIENCY WAS CONFIRMED. MANUFACTURING RECORD REVIEW: REPORTED LOT NUMBER ZE06099 WAS A PACKAGING LOT-KIT. LOT# OF THE SOLUTION WAS ZE06097. THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT ONE ADDITIONAL COMPLAINT WAS RECEIVED FOR THIS PRODUCTION ORDER. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS TO CORRECT THE INITIAL SUBMISSION. IN THE INITIAL REPORT THE FOLLOWING FIELDS WERE NOT ADDRESSED AND ARE NOW UPDATED ACCORDINGLY: SECTION D4, CATALOG NUMBER: 94019JA. SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN EXPLANTABLE DEVICE. SECTION H6, COMPONENT CODES: 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE SECTION H6, HEALTH EFFECT-CLINICAL CODE: OMIT 2038 - RED EYE(S) S THERE WAS NO REPORT OF RED EYES. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: UNKNOWN/NO INFORMATION. DATE OF EVENT: UNKNOWN/NO INFORMATION. MANUFACTURER TELEPHONE NUMBER: (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT SHE USUALLY USES COMPLETE DOUBLE MOIST MULTIPURPOSE SOLUTION BUT MISTAKENLY PURCHASED THE CONCEPT 1-STEP PEROXIDE SOLUTION. SHE USED CONCEPT 1-STEP PEROXIDE SOLUTION IN THE SAME WAY SHE NORMALLY USES COMPLETE DOUBLE MOIST MULTIPURPOSE SOLUTION AND CONSEQUENTLY EXPERIENCED SEVERE IRRITATION IN HER EYES. SHE VISITED THE EYE CLINIC WHICH PRESCRIBED EYE-DROPS AND ORAL MEDICATION. PRESCRIPTION: HYALURONATE NA OPHTHALMIC SOLUTION, CRAVIT OPHTHALMIC SOLUTION 1.5%, RINDERON 0.001%, ORAL MEDICINE (DRUG NAME WAS UNKNOWN). SHE FELT BETTER AFTER USING THE PRESCRIBED MEDICINE AND WAS TOLD THAT HER EYES HAD RECOVERED. AFTER HER EYES RECOVERED, SHE SOAKED HER CONTACT LENSES IN THE DISINFECTANT CONCEPT 1-STEP PEROXIDE SOLUTION. HER EYES GOT IRRITATED AGAIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059158 CONSEPT 1 STEP DISINFECTING SOLUTION LPN AMO(HANGZHOU) CO., LTD. 07167X ZE06099 24987617003450

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention