BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYSEPT 1

    MDR report key: 12524254 · Received September 24, 2021

    Report

    Report Number
    2020664-2021-07287
    Event Type
    Injury
    Date Received
    September 24, 2021
    Report Date
    December 16, 2021
    Manufacturer
    AMO(HANGZHOU) CO., LTD.
    Product Code
    LPN
    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? SEP 29, 2021. SECTION H3: EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: CHEMISTRY TESTING WAS CONDUCTED ON THE RETURNED SAMPLE, ALL THE TESTED ITEMS MET PRODUCT SPECIFICATION, NO PRODUCT DEFICIENCY WAS CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. COMPLAINT DATA WAS TRENDED BY THE REPORTED LOT NUMBER: ZH07081. FIVE COMPLAINTS WERE REPORTED IN PREVIOUS 12 MONTHS. NO PRODUCT DEFICIENCY WAS CONFIRMED FOR THE SIMILAR ISSUE. 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 · 1

    DATE OF EVENT: THE EXACT DATE IS UNKNOWN, THE BEST ESTIMATE IS IN THE BEGINNING OF (B)(6) 2021. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT SHE EXPERIENCED IRRITATION AND RED EYES WHEN WEARING HER CONTACT LENSES AFTER TAKING CARE OF THEM WITH CONSEPT 1-STEP SOLUTION. THIS HAPPENED AFTER USING THE SECOND BOTTLE WHICH WAS AROUND THE BEGINNING OF (B)(6) 2021. SHE WAS CONCERNED ABOUT HAVING ANY FURTHER PROBLEMS WITH HER EYES AND VISITED AN EYE CLINIC. SHE WAS DIAGNOSED WITH KERATITIS AND WAS PRESCRIBED THE FOLLOWING EYE DROPS: FLUOROMETHOLONE OPHTHALMIC SOLUTION, LEVOFLOXACIN OPHTHALMIC SOLUTION AND HYALEIN OPHTHALMIC SOLUTION. SHE WAS INFORMED THAT HER SYMPTOMS WOULD SUBSIDE IN ABOUT TWO WEEKS. SHE USED 1-DAY CONTACT LENSES FOR A WEEK TO BE SAFE. IT WAS NOTED THE USAGE OF THE PRODUCT WAS PROPER. AT THE TIME OF THIS REPORT, SHE HAD RECOVERED. HOWEVER, TOWARDS THE END OF (B)(6) 2021 THE CONSUMER RE-STARTED THE USE CONCEPT 1-STEP SOLUTION TO TAKE CARE OF HER 2-WEEK CONTACT LENSES. AGAIN, SHE EXPERIENCED IRRITATION AND RED EYES, BUT SHE RECOVERED WITH NO MEDICAL INTERVENTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422917 OXYSEPT 1 ACCESSORIES, SOFT LENS PRODUCTS LPN AMO(HANGZHOU) CO., LTD. 7167X ZH07081

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention NEUTRALIZING TABLET LOT# 89326| NEUTRALIZING TABLET LOT# 89326