BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY

    MDR report key: 17573818 · Received August 18, 2023

    Report

    Report Number
    1057985-2023-00053
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    August 1, 2023
    Report Date
    September 7, 2023
    Manufacturer
    JOHNSON & JOHNSON VISION CARE - IRELAND
    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 24AUG2023, THE PATIENT (PT) PROVIDED ADDITIONAL MEDICAL INFORMATION. EYE CARE PROFESSIONAL OFFICE VISIT DATED: (B)(6) 2023: CHIEF COMPLAINT: OD RED EYE. PT FEELS MAY HAVE SCRATCHED THE OD CORNEA. THE PT REPORTS IS A ¿HABITUAL CL WEARER AND SLEPT IN THE DAILY CL TWO NIGHTS AGO.¿ ON AWAKENING, THE PT DID NOT REMOVE THE LENSES AND WORE THEM THROUGH LAST NIGHT BEFORE BED. (WORE CL FROM SUNDAY THROUGH MONDAY NIGHT). THE PT WOKE THIS MORNING WITH IRRITATION AND FEELING LIKE THERE WAS SOMETHING IN THE EYE. THE PT WOKE RUBBING THE EYE WHICH IS WHY THE PT THINKS THERE IS A SCRATCH. THE PT IS LIGHT SENSITIVE IN THE OD, TRIED EYE WASH AND CL EYE DROPS (NAME NOT PROVIDED). THE PT FEELS THAT THE SYMPTOMS HAVE BEEN GETTING BETTER THROUGHOUT THE DAY TODAY. EYE EXAM VISION: DCC OD: 20/20; IOP: OD: 17, SLIT LAMP EXAM OD: OD CONJUNCTIVA 3+ INJECTION; OD CORNEA: CORNEAL ULCER, .2MM @ 9:00 WITH SURROUNDING EDEMA; OD ANTERIOR CHAMBER: DEEP AND QUIET. IMPRESSION/PLAN: 1. CONTACT LENS KERATOPATHY OD; PLAN: COUNSELING - CONTACT LENS KERATOPATHY OD; RX: OFLOXACIN QID X 7 DAYS. PT WILL RETURN IN 4 DAYS TO ENSURE HEALING. DISCONTINUE CL USE DURING TREATMENT. 2. CORNEAL ULCERATION OD: PLAN: COUNSELING CORNEAL ULCER. 3. HYPEREMIC CONJUNCTIVA OD: PLAN: COUNSELING ¿ CONJUNCTIVITIS. CONTACT OFFICE IF CONJUNCTIVITIS DOES. NOT IMPROVE OR WORSENS DESPITE TREATMENT OR IF VISION GETS BLURRY. FOLLOW-UP IN 4 DAYS. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : SUSPECT PRODUCT DISCARDED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A JOHNSON AND JOHNSON VISION CARE EMPLOYEE REPORTED A DIAGNOSIS OF CORNEAL ULCER (AFFECTED EYE NOT PROVIDED) WHILE WEARING AN ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY BRAND CONTACT LENS (CL). THE PT SLEPT WITH THE CONTACTS, REMOVED THE SUSPECT LENS THE NEXT NIGHT AND AWOKE THE NEXT MORNING WITH IRRITATION. ON 02AUG2023, THE PT PROVIDED ADDITIONAL INFORMATION. ON (B)(6) 2023, AN EYE CARE PROFESSIONAL (ECP) DIAGNOSED THE PT WITH AN OD CORNEAL ULCER AND PRESCRIBED OFLOXACIN OPHTHALMIC SOLUTION 0.3%. THE OFLOXACIN WAS INITIALLY PRESCRIBED 1-2 DROPS EVERY 2 TO 4 HOURS FOR THE FIRST 2 DAYS, THEN ON DAY 3, THE PT WAS INSTRUCTED TO USE THE DROPS QID. THE ECP ALSO ADVISED NO CL WEAR UNTIL FOLLOW-UP APPOINTMENT (SCHEDULED FOR ¿SATURDAY¿). THE PT WAS ADVISED ¿THE ULCER WAS AROUND THE OUTSIDE OF THE EYE,¿ AND WAS NOT ADVISED IF THE ULCER WAS INFECTIOUS OR NON-INFECTIOUS. THE MEDICAL REPORT WAS REQUESTED. ON (B)(6) 2023, A CALL WAS PLACED TO THE PT¿S TREATING ECP FOR ADDITIONAL MEDICAL INFORMATION, BUT NOTHING ADDITIONAL WAS PROVIDED. ON (B)(6) 2023, THE PT ADVISED NO CALL HAS BEEN PLACED TO THE ECP TO REQUEST THE MEDICAL REPORT, BUT ADVISED A CALL WILL BE PLACED ¿SOON. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. THIS OD CORNEAL ULCER IS BEING REPORTED AS A WORST-CASE EVENT AS WE WERE UNABLE TO VERIFY THE PT¿S DIAGNOSIS AND TREATMENT WITH THE TREATING ECP. A LOT HISTORY REVIEW WAS PERFORMED FOR THE OD LOT NUMBER PROVIDED AND REVEALED THE FOLLOWING: THE BATCH RECORDS DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. LOT NUMBER 4165400107 WAS PRODUCED UNDER NORMAL CONDITIONS. THE SUSPECT OD CL WAS DISCARDED. NO ADDITIONAL EVALUATION CAN BE CONDUCTED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329569 ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY LENSES, SOFT CONTACT, DAILY WEAR LPL JOHNSON & JOHNSON VISION CARE - IRELAND 4165400107

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention| O