BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE® OASYS®

    MDR report key: 14287435 · Received May 5, 2022

    Report

    Report Number
    1057985-2022-00034
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    March 25, 2022
    Report Date
    May 4, 2022
    Manufacturer
    JOHNSON & JOHNSON VISION CARE - IRELAND
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUSPECT CL REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A PATIENT (PT) IN (B)(6) REPORTED ¿SYMPTOMS¿ AFTER INSERTING AN ACUVUE OASYS® BRAND CONTACT LENS ON THE LEFT EYE (OS) ON (B)(6) 2022. ON 05APR2022, ADDITIONAL INFORMATION WAS PROVIDED. THE PT REPORTED OS ACUTE KERATITIS (DATE UNKNOWN). THE PT WAS TREATED WITH TOBRAMYCIN (TOBREX) 0.3% 1 DROP 4-5 TIMES A DAY, DICLOFENAC 0.1% 1 DROP 4-5 TIMES A DAY, AND KORNEREGEL 4-5 TIMES A DAY. THE PT ALSO PROVIDED A MEDICAL REPORT IN (B)(6). TRANSLATION OF THE MEDICAL REPORT WAS REQUESTED. ON (B)(6) 2022, THE PT ADVISED THE SUSPECT LENSES ARE AVAILABLE FOR RETURN AND CLS ARE NOT BEING WORN AT THIS TIME. ON 08APR2022, THE PT¿S TRANSLATED MEDICAL REPORTS WERE RECEIVED. DATE OF VISIT: (OPHTHALMOLOGIST) (B)(6) 2022. PT COMPLAINS OF LACRIMATION, REDNESS, DECREASED VISION OS FOR SEVERAL DAYS. THE PT WENT TO THE OPTICIAN 3 DAYS AGO AND WAS PRESCRIBED DICLOFENAC. THE EXAM REVEALED OS CONJUNCTIVAL INJECTION AND CORNEAL CLOUDING. THE ANTERIOR CHAMBER IS OF MEDIUM DEPTH, THE MOISTURE OF THE ANTERIOR CHAMBER IS TRANSPARENT, THE IRIS HAS A CLEAR PATTERN, THE PHOTOREACTION IS PRESERVED, THE LENS IS TRANSPARENT IN THE POSTERIOR CAPER, THE VITREOUS BODY IS TRANSPARENT. FUNDUS OF THE EYE OU: THE DZN IS PALE PINK IN COLOR, THE CONTOURS ARE CLEAR, THE VEINS ARE MODERATELY DILATED, THE ARTERIES ARE NARROWED. PERIPHERY WITHOUT PATHOLOGY. DIAGNOSIS: ACUTE KERATITIS OS. TREATMENT: TOBRAMYCIN 0.3% 1 DROP 4-5 TIMES A DAY, DICLOFENAC 0.1% 1 DROP 4-5 TIMES A DAY, AND KORNEREGEL 4-5 TIMES A DAY IN THE OS. A REQUEST WAS MADE FOR A CONSULTATION WITH A HOSPITAL OPHTHALMOLOGIST. DATE OF VISIT: (HOSPITAL OPHTHALMOLOGIST CONSULTATION) (B)(6) 2022. DIAGNOSIS: H18.8 OTHER SPECIFIED DISORDERS OF CORNEA; KERATOUVEITIS OF THE OS. RECOMMENDATIONS: OBSERVATION AND TREATMENT OF AN OPHTHALMOLOGIST, SPECTACLE CORRECTION. FENIKYMID 1 DROP 2 TIMES A DAY, NEPAFENAC 1 DROP 3 TIMES A DAY, AND DEXAMETHASONE 0.01% 1 DROP 3 TIMES A DAY (TAKE 1 ML OF DESAMETHASONE WITH A SYRINGE AND ADD TO 10 ML OF STILLAVIT SOLUTION, SHAKE, STORE IN THE REFRIGERATOR) IN THE OS. RE-ADMISSION (B)(6) 2022 ON 08APR2022, THE EVENT WAS DETERMINED TO BE A SERIOUS, REPORTABLE ADVERSE EVENT WITH THE ADDITIONAL INFORMATION RECEIVED IN THE PT¿S MEDICAL REPORTS. ON 20APR2022, A CALL WAS PLACED TO THE PT AND ADDITIONAL INFORMATION WAS PROVIDED. THE PT CONFIRMED THE DIAGNOSIS AS ¿OS ACUTE KERATITIS.¿ THE OS CONDITION IS REPORTED AS ¿SATISFACTORY,¿ THE PT CONTINUES THERAPY, AND THE PT¿S VISION IS GRADUALLY IMPROVING. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED AND NO ADDITIONAL MEDICAL INFORMATION IS EXPECTED. A LOT HISTORY REVIEW WAS PERFORMED 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 L0053PW WAS PRODUCED UNDER NORMAL CONDITIONS. THE OS SUSPECT CL WAS REQUESTED FOR EVALUATION BUT HAS NOT BEEN RECEIVED. 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
    1177386 ACUVUE® OASYS® LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE - IRELAND L0053PW

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O