BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE® VITA¿ FOR ASTIGMATISM

    MDR report key: 21316285 · Received February 5, 2025

    Report

    Report Number
    1057985-2025-0000012
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    December 18, 2024
    Report Date
    March 21, 2025
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. - US
    Product Code
    LPL
    UDI-DI
    00888290274574
    PMA / PMN Number
    K160212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6)2025 DURING A FILE REVIEW, IT WAS NOTED THAT THE FOLLOWING HEALTH EFFECT - CLINICAL CODES FOR 1940 IRITIS, 4577 - SWELLING/EDEMA, AND 4803 - EYE IRRITATION WERE OMITTED IN THE INITIAL MDR SUBMISSION ON (B)(6)2025, MDR 1057985-2025-0000012. THIS FOLLOW-UP # 1 REPORT INCLUDES THE CODES LISTED IN SECTION H.6. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED, AS APPROPRIATE.

    Description of Event or Problem · 0

    ON (B)(6)2025, A PATIENT (PT) IN MEXICO REPORTED A DIAGNOSIS OF CORNEAL ¿ULCER WITH INFECTION¿ WHILE WEARING AN ACUVUE® VITA¿ FOR ASTIGMATISM BRAND CONTACT LENSES (CLS). THE PT IS CURRENTLY IN TREATMENT (UNKNOWN) WITH A SPECIALIST. THE PT REPORTED THE TREATMENT IS ¿PROLONGED AND BASICALLY CONFINED TO MY HOME¿. THE AFFECTED EYE WAS NOT PROVIDED. ON (B)(6)2025, THE PT REPORTED DISCOMFORT AND WAS UNSURE IF THE ¿LENS WAS KEPT INSIDE OF THE EYE, AS THE PT COULD NOT REMOVE IT.¿ THE PT VISITED AN EYE CARE PROFESSIONAL (ECP), DATE NOT PROVIDED, WHO DIAGNOSED THE PT WITH A CORNEAL ULCER IN THE LEFT EYE (OS). THE PT WAS PRESCRIBED AN UNKNOWN ANTIBIOTIC EYE DROP, STEROID, AND VITAMIN E. ON (B)(6)2025, THE PT LATER PROVIDED ADDITIONAL INFORMATION. ON (B)(6)2024, THE PT OPENED A NEW CL FOR THE OS AND AFTER AN HOUR OF WEAR, THE PT BEGAN TO EXPERIENCE DISCOMFORT, TEARING, IRRITATION, AND LIGHT SENSITIVITY. THE PT WENT TO SLEEP AFTER GETTING HOME AND DID NOT HAVE A CL IN THE OS, BUT FELT LIKE THE LENS WAS IN THE EYE. THE PT WENT TO SEE AN ECP AND ADVISED THE PT OF ¿CORNEAL ABSCESS¿ AND WAS SENT STRAIGHT TO A CORNEAL SPECIALIST. THE SPECIALIST ADVISED THE PT THAT IT WAS AN ¿INFECTED CORNEAL ULCER¿ AND NO CL WAS ON THE EYE. THE PT WAS PRESCRIBED TIMOLOL 0.5%, HIPROMELOSA (LUBRICANT EYE DROPS), AND EITHER VITAMIN E OR VITAMIN C FOR THE FIRST 15 DAYS. THE PT IS STILL IN TREATMENT WITH THE CORNEA SPECIALIST AND IS CURRENTLY TAKING MOXIFLOXACIN EVERY 2 HOURS AND STEROID DROPS (NAME UNKNOWN) THREE TIMES DAILY (TID). THE PT WILL SEND THE MEDICAL REPORTS BY EMAIL. ON (B)(6)2025, THE PT CALLED TO PROVIDED ADDITIONAL INFORMATION. PT REPORTED A FOLLOW-UP VISIT ON (B)(6)2025 WITH THE OPHTHALMOLOGIST. THE PT REPORTED THE ECP FOUND ¿PROGRESS¿ AND DECREASED THE DOSAGE OF THE MOXIFLOXACIN TO QID FOR 6 DAYS, STEROID TO QID FOR 6 DAYS. THE PT HAS ANOTHER FOLLOW-UP APPOINTMENT ON (B)(6)2025 FOR A FINAL CHECK. THE PT IS FEELING BETTER AND AGREED TO PROVIDE THE MEDICAL REPORT AFTER THE NEXT VISIT. ON (B)(6)2025, TRANSLATION WAS RECEIVED OF INFORMATION SENT BY THE PT ON (B)(6)2025. THE PT SENT 9 PHOTOS WITH MEDICAL REPORTS AND PHOTOS OF THE CL BOX ON (B)(6)2025. -PHOTO 1 RECEIVED WAS A PHOTOCOPY OF THE EMAIL REQUESTING THE PT¿S MEDICAL RECORDS. -PHOTO2 IS A PHOTO OF THE PT¿S MEDICATIONS. VITAMIN C; MOXIFLOXACINO; SPLASH TEARS; FLUOROMETHOLONA SUSPENSION 1MG/ML; AND TIMOLOL 0.5%. -PHOTO 3; EMERGENCY HOSPITAL VISIT, DATED (B)(6)2024 THE PT DEVELOPED SYMPTOMS IN 4 DAYS, REFERRED AS OS OCULAR PAIN, EPIPHORA, SECRETION RELEASE, AND BLURRY VISION, THEREFORE THE PT WAS SENT TO SPECIALIST AT THE OPHTHALMOLOGY CLINIC WITH A DIAGNOSIS OF CORNEAL ABSCESS IN THE OS, SO IS HERE FOR EVALUATION. LEFT EYE WITH EPIPHORIC CONJUNCTIVAL ERYTHEMATOUS EDEMA DIAGNOSIS: CORNEAL ABSCESS, LEFT EYE CURRENT CONDITION: DAYS BEFORE, PT HAS HAD PHOTOPHOBIA, THICK DISCHARGE FROM THE LEFT EYE, BURNING, PAIN. VISUAL ACUITY IN THE RIGHT EYE CD (COUNTING FINGERS). -PHOTO 4, CONTINUATION OF PHOTO 3, VISUAL ACUITY OS: 20/40 INTRAOCULAR PRESSURE (IOP) OS: 17 MMHG BIOMICROSCOPY OS: ¿EYELIDS WITHOUT ALTERATIONS, HYPEREMIC CONJUNCTIVA, OPACIFIED CORNEA, PARACENTRAL ULCER WITH PURULENT BASE. INFECTIOUS INFILTRATE WITH WELL-DEFINED EDGES THAT STAINS WITH FLUORESCEIN INSTALLATION, ANTERIOR CHAMBER FORMATION, REACTION IN ANTERIOR CHAMBER FLARE+** +** TYNDALL +* REACTIVE IRIS, CLEAR LENS¿. PLAN: PT DISCHARGED; OCULAR LUBRICANT AS NEEDED. HYDROXYPROPYL METHYLCELLULOSE EVERY 4 HOURS, MOXIFLOXACIN OPHTHALMIC SOLUTION 1 DROP EVERY 2 HRS LEFT EYE; DOXYCYCLINE 100 MG, 1 TABLET EVERY 12 HOURS, VITAMIN C, 1 GRAM ORALLY EVERY 24 HOURS, TIMOLOL BRIMONIDINE 1 DROP EVERY 12 HOURS, OS. PROGNOSIS: RESERVED -PHOTO 5: SAME AS PHOTO 3, BUT SHOWS PT¿S VITAL SIGNS FROM EMERGENCY VISIT. -PHOTO 6: PHOTO OF CL BOX, LOT NUMBER B0143NH. -PHOTO 7: CLINICAL RECORD A PT HAD THE FOLLOWING FINDINGS ACCORDING TO HIS OPHTHALMOLOGIC REVISION. IOP OS: 15 ¿CONTACT LENS USER REPORTS HOURS OF USE, 6 DAYS AGO PUT IN LENS, HAD SCE AND REMOVED IT, YESTERDAY PUT IT IN AGAIN. AND REPORTS THAT ONLY HAS IMPORTANT TEARING, ABUNDANT SECRETION, AND APPLIES OPHTHALMIC DICLOFENAC, WHICH ALREADY HAD, AND REPORTS THAT PT¿S GLASSES HAVE NOT BEEN REMOVED.¿ BIOMICROSCOPY: LEFT EYE: NORMAL EYELIDS; CONJUNCTIVA, EPISCLERAL VESSELS; CORNEA ABSCESS; FORMED ANTERIOR CHAMBER; IRIS WITHOUT ALTERATIONS; AFFERENT PUPILLARY DEFECT: NO PHOTOMETER: NO CONSENSUAL: NO TRANSPARENT VITREOUS. PHOTO 8 AND PHOTO 9, SAME EMERGENCY VISIT RECORD. NO NEW INFORMATION. ON (B)(6)2025, THE PATIENT (PT) PROVIDED ADDITIONAL INFORMATION. THE PT WENT TO THE ECP ON (B)(6)2025 FOR FOLLOW-UP VISIT. THE PT REPORTED THE EYE CARE PROFESSIONAL (ECP) ADVISED THAT THE EYE WAS DOING BETTER AND IS ALMOST RECOVERED. THE PT WAS ADVISED TO FINISH THE ANTIBIOTIC MEDICATION AND RETURN TO CL WEAR IN 2 WEEKS. THE PT WAS ADVISED TO CONTINUE THE STEROID DROP FOR THE 6 WEEKS AS IT WAS PRESCRIBED, UNTIL COMPLETION. ON (B)(6)2025, TRANSLATION RECEIVED OF THE ADDITIONAL INFORMATION PROVIDED BY THE PT ON (B)(6)2025. PHOTO 1 CONTAINS A HANDWRITTEN PAPER WITH TREATING ECP INFORMATION AND ADDRESS PHOTO 2 CONTAINS A HANDWRITTEN PAPER WITH TREATMENT PRESCRIBED: FLUOROMETHOLONE (CORTICOSTEROID): 1DROPT EVERY 4 HOURS FOR 7 DAYS, THEN, 1 DROP EVERY 6 HOURS FOR 7 DAYS, THEN 1 DROP EVERY 8 HOURS FOR 7 DAYS, THEN 1 DROP EVERY 12 HOURS FOR 7 DAYS, THEN 1 DROP EVERY 24 HOURS FOR 7 DAYS, THEN SUSPEND USE. ¿IN 2 WEEKS, RETURN TO USE THE CONTACT LENS¿ SODIUM HYALURONATE SYSTANE HYABAK.¿ ON (B)(6)2025, THE PT PROVIDED ADDITIONAL INFORMATION. THE PT REPORTED THE EYE WAS¿ FINE AND RECOVERED,¿ JUST NEED TO USE THE MEDICATION 2 MORE DAYS, THEN RESUME CL WEAR. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. NO ADDITIONAL 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 B0143NH WAS PRODUCED UNDER NORMAL CONDITIONS. THE SUSPECT OS CL WAS DISCARDED. NO ADDITIONAL EVALUATION CAN BE PERFORMED. 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
    1042852 ACUVUE® VITA¿ FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR LPL JOHNSON & JOHNSON VISION CARE, INC. - US B0143NH 00888290274574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| S| O