BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ABILITI¿ OVERNIGHT

    MDR report key: 22974540 · Received September 4, 2025

    Report

    Report Number
    1000188353-2025-00007
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    August 4, 2025
    Report Date
    November 6, 2025
    Manufacturer
    MENICON B.V.
    Product Code
    NUU
    PMA / PMN Number
    P990018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMPORTER'S INFORMATION - ESTABLISHMENT NAME: JOHNSON AND JOHNSON VISION CARE, INC. ADDRESS: (B)(6) TELEPHONE NUMBER: (B)(6) EMAIL ADDRESS: (B)(6) IMPORTER SENT REPORT TO FDA - SUBMISSION DATE: (B)(6) 2025 IMPORTER REPORT NUMBER: (B)(4).

    Description of Event or Problem · 0

    ON 06AUG2025, JOHNSON AND JOHNSON VISION CARE (JJVC) EMPLOYEE SENT AN EMAIL TO THE ACUVUE ABILITI¿ OVERNIGHT BRAND CONTACT LENS (CL) MANUFACTURING SITE (MENICON B.V.) INFORMING THEM OF THE FOLLOWING ADVERSE EVENT. MENICON B.V. RECORDED IT AS COMPLAINT ID (B)(4) AND INFORMED THE MANUFACTURER (MENICON CO.). - ADVERSE EVENT INFORMATION - ON (B)(6) 2025, THE PATIENT WEARING ACUVUE ABILITI¿ OVERNIGHT CONTACT LENSES NOTICED SYMPTOMS OF EYE PAIN AND WATERY EYES. THE FOLLOWING DAY, (B)(6) 2025, THE PATIENT VISITED THE ECP, DIAGNOSED WITH A RIGHT EYE (OD) SMALL CENTRAL CORNEAL ULCER AND WAS TREATED WITH VIGAMOX EVERY 2 HOURS. THE PATIENT LAST WORE THE LENSES ON (B)(6) 2025. THE PATIENT HAD BEEN USING THE LENSES OVERNIGHT FOR APPROXIMATELY 1 TO 3 MONTHS, WITH A DAILY REPLACEMENT SCHEDULE. THERE WAS NO INDICATION OF LENS MISUSE, AND THE PATIENT'S LENS CARE PRACTICES WERE CONSIDERED APPROPRIATE. THE EXACT CAUSE OF THE CORNEAL ULCER REMAINS UNDETERMINED. THE PATIENT DISCONTINUED LENS WEAR FOLLOWING THE ONSET OF SYMPTOMS AND HAS BEEN UNDERGOING TREATMENT. AS OF THE DATE OF THE VISIT, THE INJURY HAD NOT YET RESOLVED, AND THE PATIENT WAS STILL IN RECOVERY. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. THE SUSPECT LENS LOT NUMBER HAS BEEN REPORTED AS 25131437R1. THERE WERE NO DEVIATIONS FOUND IN THE MANUFACTURING PROCESS. IT IS CURRENTLY UNKNOWN WHETHER THE ACTUAL LENS IS AVAILABLE FOR EVALUATION. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MENICON RECEIVED THE ACTUAL LENSES FROM THE PATIENT ON 13OCT2025 AND CONDUCTED THE INVESTIGATION ON 14OCT2025. DETAILS OF THE INVESTIGATION RESULTS ARE SHOWN IN B6. THE CONCLUSION OF THE INVESTIGATION WAS THAT NO ABNORMALITIES WERE FOUND. NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S OUTCOME HAS BEEN RECEIVED TO DATE. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131635 ACUVUE ABILITI¿ OVERNIGHT LENS, CONTACT, ORTHOKERATOLOGY, OVERNIGHT NUU MENICON B.V. 25131437R1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| O| S UNIQUE PH.