BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ABILITI¿ OVERNIGHT

    MDR report key: 21639997 · Received March 19, 2025

    Report

    Report Number
    1000188353-2025-00005
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    July 1, 2024
    Report Date
    March 19, 2025
    Manufacturer
    MENICON B.V.
    Product Code
    NUU
    UDI-DI
    00192538951357
    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: (B)(6), IMPORTER SENT REPORT TO FDA, SUBMISSION DATE: MAR 10, 2025, IMPORTER REPORT NUMBER: 1057985 - 2025 - 0000025.

    Description of Event or Problem · 0

    ON 27FEB2025, 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 13FEB2025, AN EMAIL SENT BY A JOHNSON AND JOHNSON EMPLOYEE ADVISED A PATIENT (PT) WAS DIAGNOSED WITH A "POSSIBLE CORNEAL INFECTION" WITH A RESULTING SCAR THAT DOES NOT IMPACT THE VISUAL ACUITY (VA) WHILE WEARING AN ACUVUE ABILITI¿ OVERNIGHT BRAND CL. ON (B)(6) 2025, ADDITIONAL INFORMATION WAS RECEIVED. THE TREATING EYE CARE PROFESSIONAL (ECP) REPORTED THE PT EXPRESSED SYMPTOMS OF "UNCOMFORTABLE AND IRRITATED" WHILE WEARING THE LEFT EYE (OS) CL ON (B)(6) 2024. THE PT WAS SEEN ON (B)(6) 2024 WITH FINDINGS OF CENTRAL CORNEAL EDEMA AND LIGHT SENSITIVITY. THE PT WAS PRESCRIBED LOTEMAX FOUR TIMES DAILY (QID). THE PT WAS SEEN BY THE ECP FOR ADDITIONAL FOLLOW-UP (FU) VISITS ON (B)(6) 2024. THE ECP REPORTS THAT THE PT WAS ALSO SEEN ON (B)(6) 2025 AND IS 20/20 WITH OU CORRECTION. ON 28FEB2025, WE OBTAINED ADDITIONAL INFORMATION FROM JJVC. THE TREATING ECP REPORTED THE PT HAD WHAT LOOKED LIKE A "CORNEAL INFILTRATE, NOT INFECTIVE, AND NOT CORNEAL INFECTION THE OS, THAT RESOLVED WITH LOTEMAX QID IN 1 WEEK." THE ECP STATED THAT IT LOOKED LIKE A "TYPICAL INFILTRATE" SEEN IN PT'S USING SOFT CONTACT LENSES. THE ECP ADVISED IT MAY BE "DUE TO HYPOXIA" AND "NOT CORNEAL INFECTION OR BACTERIA AS THE PT WAS NOT TREATED WITH ANTIBIOTICS AND RESOLVED USING ONLY STEROIDS." THE PT WAS LEFT WITH A CENTRAL MILD SCAR, NOT AFFECTING THE VA. THE PT COMPLETED ALL FU AND ALL ISSUES RESOLVED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9242 ACUVUE ABILITI¿ OVERNIGHT LENS, CONTACT, ORTHOKERATOLOGY, OVERNIGHT NUU MENICON B.V. 23346047L1 00192538951357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| S| R BOSTON SIMPLUS SOLUTION.