BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSEPT 1 STEP LL

    MDR report key: 17631247 · Received August 28, 2023

    Report

    Report Number
    3012236936-2023-02063
    Event Type
    Injury
    Date Received
    August 28, 2023
    Report Date
    November 20, 2023
    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

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: 01-SEP-2023. SECTION H3: DEVICE EVALUATED BY MANUFACTURER? YES. CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT "G4" FIELDS ¿PMA/510(K) NUMBER¿ AND ¿COMBINATION PRODUCT¿ WERE INADVERTENTLY LEFT BLANK ON THE INITIAL MDR; THEREFORE, THE INFORMATION HAS BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY: SECTION G4: PMA/510(K) NUMBER: P850088. SECTION G4: COMBINATION PRODUCT: NO. DEVICE EVALUATION: THREE CONSEPT 1-STEP BOTTLES, LOT ZK07274, WERE RETURNED TO THE MANUFACTURING SITE FOR EVALUATION: 1 BOTTLE WAS USED; 2 BOTTLES WERE UNOPENED. A CHEMICAL TEST WAS PERFORMED WITH THE USED BOTTLE AND A MICROBIOLOGICAL TEST WITH ONE UNUSED BOTTLE. ALL THE TESTED ITEMS MET PRODUCT SPECIFICATION. THE CHEMICAL TESTING REPORT REVEALED THAT THE APPEARANCE WAS A CLEAR AND COLORLESS SOLUTION PRACTICALLY FREE FROM PARTICULATE MATTER, 3.4 WAS THE PH. THE TABLET NEUTRALIZATION AND DISSOLUTION SHOWED 0PPM WITHIN 240 MINUTES AND DISSOLVED COMPLETELY WITHIN 360 MINUTES. THE HYDROGEN PEROXIDE ASSAY WAS 3.1%. THE MICRO TESTING REPORT REVEALED THAT AFTER INCUBATION, THERE WAS NO BACTERIAL GROWTH IN THE NEGATIVE CONTROL AND SAMPLE CULTURE MEDIA. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - OTHER (81): THE PRODUCT 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. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, NO DEFINITIVE 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 THAT AFTER USE OF THE CONSEPT 1-STEP (300 ML X 3), THE USER SUFFERED AN INFLAMMATION IN HER EYES RECENTLY. FIRST, EYE MUCUS CAME OUT OF HER EYES, BUT SHE DID NOT MIND. BUT, THE FOLLOWING DAY, SHE HAD SEVERE IRRITATION IN HER EYES THAT SHE COULD NOT OPEN HER EYES AFTER WEARING HER CONTACT LENSES THAT WERE TAKEN CARE OF WITH THE PRODUCT. ALSO, A LOT OF EYE MUCUS CAME OUT, WHICH MADE HER VISION WHITEY. SHE VISITED AN EYE CLINIC AND THEY ADVISED NOT TO USE CONTACT LENSES FOR A WEEK AND THEY PRESCRIBED SOME DRUGS. AFTER USING THE DRUG, THE SYMPTOMS SUBSIDED. HOWEVER, WHEN SHE USED HER CONTACT LENSES AGAIN SHE FELT STRANGE WITH HER EYES IN THE NIGHT. THE FOLLOWING MORNING, SYMPTOMS IN HER EYES WERE WORST THAN BEFORE. HER EYES BECAME RED AND LARGE AMOUNT OF EYE MUCUS CAME OUT. SHE VISITED THE CLINIC AGAIN AND MORE MEDICATIONS WERE PRESCRIBED. SHE FINISHED USING THE DRUG ON (B)(6) 2023 AND HAS RECOVERED AS OF THE FOLLOWING DAY (DAY EVENT WAS REPORTED TO JOHNSON AND JOHNSON VISION). DIAGNOSIS: NO SPECIFIC DIAGNOSIS WAS GIVEN. SHE WAS TOLD THAT SHE HAD INFLAMMATION IN HER EYES AT THE FIRST VISIT, AND AT THE SECOND VISIT, SHE WAS TOLD THAT IT COULD BE CAUSED BY THE EYE CARE PRODUCT. IT WAS INDICATED THAT THE OXYCUP HAD NO BREAKAGE OR CRACKS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328774 CONSEPT 1 STEP LL ACCESSORIES, SOFT LENS PRODUCTS LPN AMO(HANGZHOU) CO., LTD. 7167X ZK07274

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R NEUTRALIZING TABLETS, LOT UNKNOWN