BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE® OASYS®

    MDR report key: 15714389 · Received November 2, 2022

    Report

    Report Number
    1057985-2022-00086
    Event Type
    Injury
    Date Received
    November 2, 2022
    Date of Event
    January 1, 2012
    Report Date
    November 2, 2022
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. - US
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUSPECT PRODUCT DISCARDED.

    Description of Event or Problem · 0

    ON (B)(6) 2022 A PATIENT (PT) IN ARGENTINA REPORTED A DIAGNOSIS OF CORNEAL ULCER (AFFECTED EYE NOT PROVIDED) WHILE WEARING THE A ACUVUE® OASYS® WITH HYDRACLEAR PLUS BRAND CONTACT LENS (CL). ON (B)(6) 2022, THE PT PROVIDED ADDITIONAL INFORMATION. THE PT REPORTED AN OS CORNEAL ULCER THAT OCCURRED ABOUT 10 YEARS AGO AND THE EVENT WAS PREVIOUSLY REPORTED TO JOHNSON AND JOHNSON VISION CARE, INC. A SEARCH OF THE COMPLAINT HANDLING SYSTEM PRODUCED A NON-REPORTABLE EVENT THAT OCCURRED IN 2016. THE PT¿S OS CORNEAL ULCER EVENT IS BEING REPORTED AS A WORST-CASE AS WE WERE UNABLE TO VERIFY THE PT¿S DIAGNOSIS AND TREATMENT. THE LOT NUMBER OF THE SUSPECT OS CL IS UNKNOWN AND THE OS SUSPECT PRODUCT IS NOT AVAILABLE. THE DATE OF THE PT¿S EVENT IS BEING RECORDED AS (B)(6) 2012 AS THE EVENT DATE IS UNKNOWN. NO ADDITIONAL MEDICAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2913080 ACUVUE® OASYS® LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. - US UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O