BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ABILITI¿ OVERNIGHT

    MDR report key: 24961407 · Received April 22, 2026

    Report

    Report Number
    1000188353-2026-00004
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 23, 2026
    Manufacturer
    MENICON B.V.
    Product Code
    NUU
    PMA / PMN Number
    P990018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMPORTER'S INFORMATION ESTABLISHMENT NAME: (B)(6). IMPORTER SENT REPORT TO FDA. SUBMISSION DATE: 20APR2026. IMPORTER REPORT NUMBER: (B)(4).

    Description of Event or Problem · 0

    ON 30MAR2026, 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 26MAR2026, A JOHNSON AND JOHNSON CLINICAL SALES SPECIALIST SENT AN EMAIL TO ADVISE THAT AN OPTOMETRIST FIT A YOUNG PATIENT (PT) IN CANADA IN ACUVUE? ABILITI¿ OVERNIGHT "ABOUT 4 MONTHS AGO." THE REPRESENTATIVE ADVISED THAT ALL FOLLOW-UPS WERE PROVIDED WITH NO ISSUES. TODAY, 26MAR2026, THE EYE CARE PROFESSIONAL (ECP) ADVISED THAT THE PT CAME IN WITH A "CORNEAL INFECTION" IN THE LEFT EYE (OS) YESTERDAY, ON (B)(6) 2026. THE PT WOKE UP WITH A SWOLLEN EYELID AND THE "CORNEA LOOKED 'CRACKED' AND COULD NOT OPEN THE EYE WITH LOTS OF PAIN." THE PT REPORTED EXPERIENCING BURNING, STINGING, AND EYE PAIN. THE ECP DISCONTINUED CONTACT LENS WEAR. THE PT WAS PRESCRIBED VIGAMOX EYE DROPS "EVERY HOUR AROUND THE CLOCK WITH ORAL ANTIBIOTICS." THE ECP SAW THE PT FOR FOLLOW-UP "LAST SUNDAY AND EVERYTHING WAS GOOD THEN." THE ECP HAD THE OS CORNEA CULTURED ON (B)(6) 2026 AND THE "PT'S LENS THIS SATURDAY." THE ECP REPORTED THE PT AND PT'S PARENTS ARE "VERY CLEAN AND COMPLIANT WITH ALL LENS HANDLING AND CLEANING/DISINFECTION. THE OS LENS COULD HAVE SCRATCHED THE CORNEA DURING SLEEP." THE REPRESENTATIVE ADVISED THAT THE DIAGNOSIS IS" CORNEAL INFECTION UNKNOWN ORGANISM." ON (B)(6) 2026, A CALL WAS PLACED TO THE CLINICAL SALES SPECIALIST FOR ADDITIONAL INFORMATION. THE SPECIALIST COULD ONLY VERIFY THAT IT WAS A "CORNEAL INFECTION" AND IT IS UNKNOWN WHAT "TYPE OF INFECTION IT WILL BE." THE SUSPECT CL WAS "SENT TO A HOSPITAL TO BE CULTURED AND THAT RESULTS ARE NOT AVAILABLE AS OF TODAY." NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2026, A CALL WAS PLACED TO THE EYE CARE PROVIDER'S OFFICE FOR ADDITIONAL INFORMATION, BUT NOTHING ADDITIONAL WAS PROVIDED. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS PROVIDED FROM THE CLINICAL SALES SPECIALIST. THE "OPTOMETRIST IS WAITING FOR THE LAB RESULTS FROM THE HOSPITAL FROM THE CORNEAL AND LENS CULTURE SWAP." NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2026, THE CLINICAL SALES SPECIALIST PROVIDED ADDITIONAL INFORMATION. "THE DOCTOR UPDATED THAT THE LAB RESULTS HAVE RULED OUT ANCANTHOMOEBA. THEY ARE NOW WAITING TO SEE IF IT IS PSEUDOMONAS." THE LENS INVOLVED IN THIS EVENT COULD NOT BE OBTAINED, AND THE LOT NUMBER OF THE LENS IS UNKNOWN. THEREFORE, A DETAILED INVESTIGATION COULD NOT BE CONDUCTED AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333321 ACUVUE ABILITI¿ OVERNIGHT LENS, CONTACT, ORTHOKERATOLOGY, OVERNIGHT NUU MENICON B.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O