BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY

    MDR report key: 20917385 · Received December 12, 2024

    Report

    Report Number
    1057985-2024-0000096
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    November 19, 2024
    Report Date
    January 14, 2025
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. - US
    Product Code
    LPL
    PMA / PMN Number
    K042275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 14JAN2025, DURING A FILE REVIEW, IT WAS NOTED THAT MDR # FU # 1, 1057985-2024-0000096 SUBMITTED ON 09JAN2025, THE AWARENESS DATE WAS INCORRECTLY NOTED AS 16JAN2025. THE CORRECT AWARENESS DATE IS 16DEC2024. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED, AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    ON 16DEC2024, MW5162905 WAS RECEIVED FROM JOHNSON AND JOHNSON VISION CARE REGULATORY DEPARTMENT. THE PT PROVIDED ADDITIONAL INFORMATION, ¿I RECENTLY SWITCHED TO ACUVUE OASYS - HYDRALUXE CONTACT LENSES A FEW MONTHS AGO. ON (B)(6) 2024, I WOKE UP WITH SEVER LEFT EYE PAIN AND THOUGHT MY EYE WAS SCRATCHED OR HAD SOMETHING IN IT. AS THE DAY PROGRESSED MY VISION GOT WORSE AND BLURRY. I SAW MY OPHTHALMOLOGIST ON (B)(6) 2024 AND I WAS DIAGNOSED WITH A CORNEA ULCER, THE ULCER WAS DIRECTLY ON MY PUPIL. I AM ON A STRICT MEDICATION PLAN AND HAVE TO SEE THE DOCTOR EVERY DAY UNTIL IT IS HEALED. I AM STILL UNABLE TO SEE CLEARLY, AND THE ULCER IS SLOWLY HEALING. THE DOCTOR BELIEVES IT IS FROM THE ACUVUE OASYS - HYDRALUXE CONTACT LENSES." ADDITIONAL ATTEMPTS WERE MADE TO THE PT BY TELEPHONE AND EMAIL ON 20DEC2024 AND 09JAN2024 REQUESTING ADDITIONAL MEDICAL AND PRODUCT INFORMATION, BUT NOTHING ADDITIONAL HAS BEEN RECEIVED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED, AS APPROPRIATE.

    Description of Event or Problem · 0

    ON (B)(6)2024, A PATIENT (PT) REPORTED THE LEFT EYE (OS) "FELT THAT IT HAD BEEN SCRATCHED" ON (B)(6)2024 AND "MY EYE GREW A WHILE SPOT AND MY VISION WAS BLURRED. I WENT TO SEE MY OPHTHALMOLOGIST ON (B)(6)2024 AND I WAS DIAGNOSED WITH A CORNEA ULCER ON THE CENTER OF MY PUPIL. I AM NOT UNDER HIS TREATMENT, SEEING HIM DAILY AND ON A RIGOROUS MEDICATION SCHEDULE TO STOP THE ULCER FROM GROWING AND CAUSING PERMANENT DAMAGE. HE BELIEVES THE ULCER CAME FROM THESE CONTACT LENSES I RECENTLY SWITCHED TO." THE REPORTED LENSES ARE ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY BRAND CONTACT LENSES (CLS). ATTEMPTS WERE MADE TO CONTACT THE PT FOR ADDITIONAL COMPLAINT AND MEDICAL INFORMATION BY PHONE AND EMAIL ON 22NOV2024, 26NOV2024, 04DEC2024, AND 11DEC2024 WITH NO SUCCESS. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE SUSPECT OS LOT NUMBER IS UNKNOWN. AVAILABILITY OF THE OS SUSPECT CL IS UNKNOWN. NO ADDITIONAL EVALUATION CAN BE CONDUCTED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED, AS APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1924217 ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY LENSES, SOFT CONTACT, DAILY WEAR LPL JOHNSON & JOHNSON VISION CARE, INC. - US UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R