BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ABILITI¿ OVERNIGHT

    MDR report key: 23874428 · Received December 23, 2025

    Report

    Report Number
    1000188353-2025-00009
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    October 21, 2025
    Report Date
    March 2, 2026
    Manufacturer
    MENICON B.V.
    Product Code
    NUU
    UDI-DI
    00884465091014
    PMA / PMN Number
    P990018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMPORTER'S INFORMATION ESTABLISHMENT NAME : JOHNSON AND JOHNSON VISION CARE, INC. ADDRESS : 7500 CENTURION PARKWAY, JACKSONVILLE FLORIDA 32256 TELEPHONE NUMBER : (B)(4) CONTACT PERSON : (B)(4) EMAIL ADDRESS: : [email protected] IMPORTER SENT REPORT TO FDA SUBMISSION DATE : 16DEC2025 IMPORTER REPORT NUMBER : 1057985 - 2025 - 0000114.

    Description of Event or Problem · 0

    MENICON RECEIVED THE ACTUAL LENS FROM THE PATIENT AND CONDUCTED THE INVESTIGATION ON 02FEB2026. 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.

    Description of Event or Problem · 0

    ON 03DEC2025, 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. INFORMED THE MANUFACTURER (MENICON CO.). - ADVERSE EVENT INFORMATION - ON (B)(6) 2025, A PATIENT'S (PT) FAMILY MEMBER CALLED TO REPORT THE PT WAS DIAGNOSED WITH "CORNEAL ULCERS IN BOTH EYES" WHILE WEARING ACUVUE? ABILITI¿ OVERNIGHT BRAND CONTACT LENSES (CLS). THE EVENT DATE IS REPORTED AS (B)(6) 2025 AND THE PT WAS SEEN IN URGENT CARE. ON (B)(6) 2025, A CALL WAS PLACED TO THE PT'S FAMILY MEMBER TO REQUEST ADDITIONAL INFORMATION. THE FAMILY MEMBER WAS CURRENTLY WORKING AND WILL CALL LATER IN THE DAY TO PROVIDE ADDITIONAL INFORMATION. ON (B)(6) 2025 THE PT'S FAMILY MEMBER PROVIDED ADDITIONAL INFORMATION. THE PT WOKE UP IN MID-OCTOBER ONE MORNING AND COULD NOT OPEN THE LEFT EYE (OS). THE PT REPORTED PAIN, DISCHARGE AND LIGHT SENSITIVITY. THE PT WAS SEEN AT URGENT CARE AND PRESCRIBED OFLOXACIN EYE DROPS. ON THE SAME DAY, THE PT WAS THEN SEEN BY THE PRESCRIBING ECP AND PRESCRIBED A DIFFERENT ANTIBIOTIC, MOXIFLOXACIN EVERY 2 HOURS FOR THE FIRST 3 DAYS, THEN THREE TIMES DAILY (TID) UNTIL THE FOLLOW-UP VISIT. THE PT WAS SEEN FOR "MULTIPLE RECHECKS" INCLUDING 3 DAYS AFTER THE CORNEAL ULCER DIAGNOSIS. THE FAMILY MEMBER ADVISED THAT THE ULCER HAD RESOLVED AND THE PT IS CURRENTLY WEARING GLASSES. THE PT WORE THE LENSES FOR ABOUT 8 HOURS EVERY NIGHT AND HAD ONLY RECEIVED THE LENSES 1 MONTH PRIOR TO THE CORNEAL ULCER DIAGNOSIS. THE PT WOULD SOAK THE LENSES IN HYDROGEN PEROXIDE "WITH RED CAP" ABOUT 2 HOURS A DAY, THEN SOAK THE LENSES IN BOSTON SOLUTION FOR HARD LENSES UNTIL REINSERTION EACH NIGHT. THE FAMILY MEMBER ADVISED THE EYE CARE PROFESSIONAL (ECP) "DISCUSSED REFITTING THE CLS AS THE CAUSE COULD HAVE BEEN A FIT ISSUE BUT THE DOCTORS WEREN'T CERTAIN WHAT CAUSED THE ULCERS." THE FAMILY MEMBER "IS NOT COMFORTABLE FOR THE PT TO CONTINUE WITH THE ABILITI WEAR DUE TO HAVING ULCERS IN BOTH EYES AND DOESN'T WANT TO RISK PERMANENT CORNEAL DAMAGE TO PT." ON (B)(6) 2025, A CALL WAS PLACED TO THE PT'S PRESCRIBING ECP FOR ADDITIONAL DETAILS, BUT NOTHING ADDITIONAL WAS PROVIDED. ON (B)(6) 2025, A CALL WAS PLACED TO THE FAMILY MEMBER WHO AGREED TO SEND THE PT'S MEDICAL REPORTS FOR REVIEW. ECP VISIT: (B)(6) 2025 PATIENT REASON: OS POSSIBLE CORNEAL ULCER, PT FELT DISCOMFORT AND WATERY, CANNOT OPEN EYES, WENT TO URGENT CARE THAT MORNING WHERE PT RECEIVED PROPARACAINE AND FLUORESCEIN IN EYE BUT THEY DID NOT SEE AN ULCER STARTED THAT MORNING, WAS NOT GIVEN ANY MEDICATIONS AT URGENT CARE. ASSOCIATED SYMPTOMS: REDNESS, ITCHINESS, AND SHARP/THROBBING PAIN, OS EYELID IS SWOLLEN. LAST WORE ORTHO K LENS NIGHT BEFORE AND DID NOT RECALL ANY SHARP SHOOTING PAIN AFTER REMOVAL OR INSERTION LAST WEEK. VA EXAMINATION: AIDED PINHOLE VA: OS: 20/30 UNCORRECTED VA: OS: 20/40-1 INTRAOCULAR PRESSURE: OS: 12 SLIT LAMP OS: ADNEXA: NL; ANTERIOR CHAMBER: DEEP & QUIET; BULB CONJ: INJ 2 CORNEA: CENTRAL ULCER; EPISCLERA: CLEAR; IRIS: FLAT AND CLEAR; LENS/ PALPEBRAL CONJ/ SCLERA: CLEAR COMMENT: VERTICALLY ORIENTED CORNEAL ULCER NASAL TO CENTRAL AXIS- STAINS WITH WELL DEMARCATED MARGINS, NO FEATHERY APPEARANCE +2 MUCUS DEBRIS IN TEAR FILM DIAGNOSIS: CENTRAL CORNEAL ULCER, LEFT EYE EYE CARE PLAN: DISCONTINUE CLS IN BOTH EYES AND USE BACK UP PAIR OF GLASSES IN THE NEXT WEEK AS OS HEALS START MOXIFLOXACIN EVERY 2 HOURS FOR 24 HOURS, THEN TAPER FOUR TIMES DAILY (QID) FOR 6 DAYS, USE COPIOUS AMOUNTS OF PRESERVATIVE FREE ARTIFICIAL TEARS TO PROMOTE CORNEAL HEALING; FOLLOW UP FOR CORNEA CHECK IN 2 DAYS OR ASAP IF CONDITION WORSENS PT TO BRING IN LENSES IN 2 DAY FOLLOW UP FOR QUALITY CHECK AND DEEP CLEANING IN BOSTON SIMPLUS SOLUTION. ECP VISIT: (B)(6) 2025 PATIENT REASON: PT WAS MUCH BETTER, NO PAIN OR GUNK IN THE MORNING AND EYE LOOKING A LOT LESS RED, GOOD COMPLIANCE WITH EYE DROPS, FORGOT ONE DOSE AROUND AFTERNOON ON DAY OF VISIT, HAS BEEN OUT OF LENS WEAR FOR 3 DAYS. VA EXAMINATION: UNCORRECTED VA: OS 20/100-1; INTRAOCULAR PRESSURE: OS: 11 SLIT LAMP OS: ADNEXA: NL; ANTERIOR CHAMBER: DEEP & QUIET; BULB CONJ: CLEAR CORNEA: CENTRAL ULCER; EPISCLERA: CLEAR; IRIS: FLAT AND CLEAR LENS/ PALPEBRAL CONJ/ SCLERA: CLEAR COMMENT: SMALL CORNEAL OPACITY NASAL, RESOLVING FASTER THAN EXPECTED, TRACE STAINS, NO DISCHARGE OR REDNESS. DIAGNOSIS: CENTRAL CORNEAL ULCER, LEFT EYE EYE CARE PLAN: HEALING FASTER THAN EXPECTED, CONTINUE MOXIFLOXACIN FOR FULL 7 DAYS, ONCE FINISHED OK TO RETURN TO LENS WEAR AND RETURN 1 DAY FOLLOW UP FOR CORNEA CHECK. ECP VISIT: (B)(6) 2025 PATIENT REASON: 1 DAY CORNEA CHECK AFTER RETURNING TO CL WEAR, PT HAD ULCER ABOUT 1.5 WEEKS AGO OS, RESOLVED WITH NO LASTING PROBLEMS, NO PROBLEMS WITH INSERTION OR REMOVAL, NO SCRATCHY SENSATION, NO SHARP SHOOTING PAIN, NO RUBBING EYES AT NIGHT, INITIAL LENS AWARENESS WHEN FIRST PUTTING ON BUT COMFORTABLE WHILE WEARING TO SLEEP. VA EXAMINATION: UNCORRECTED VA: OS 20/60 SLIT LAMP OS: ADNEXA: NL; ANTERIOR CHAMBER: DEEP & QUIET; BULB CONJ: CLEAR CORNEA: CLEAR; EPISCLERA: CLEAR; IRIS: FLAT AND CLEAR; LENS/ PALPEBRAL CONJ/ SCLERA: CLEAR COMMENT: NO CORNEAL STAINING DIAGNOSIS: MYOPIA, BILATERAL EYE CARE PLAN: CONTINUE ORTHO K CL WEAR, DUE FOR 3 MONTH FOLLOW-UP IN 2 MONTHS. THIS REPORT IS FOR THE PT'S OS CORNEAL ULCER. NO CORNEAL ULCER WAS DIAGNOSED FOR THE PT'S OD. THE SUSPECT LENS LOT NUMBER HAS BEEN REPORTED AS 25191669. THERE WERE NO DEVIATIONS FOUND IN THE MANUFACTURING PROCESS. THE ACTUAL LENS HAS BEEN REQUESTED TO BE RETURNED TO MENICON B.V. FOR FURTHER EVALUATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION IS EXPECTED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2780263 ACUVUE ABILITI¿ OVERNIGHT LENS, CONTACT, ORTHOKERATOLOGY, OVERNIGHT NUU MENICON B.V. 25191669 00884465091014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O| S