BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE (NARA A)

    MDR report key: 5851624 · Received August 5, 2016

    Report

    Report Number
    1033553-2016-00078
    Event Type
    Injury
    Date Received
    August 5, 2016
    Date of Event
    June 17, 2016
    Report Date
    July 12, 2016
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ON (B)(6) 2016 AN EMAIL WAS RECEIVED FROM AN ONLINE PROVIDER REPORTING THAT A PATIENT (PT) HAD A CORNEAL ULCERATION A FEW WEEKS AGO. THE PT WAS REPORTED TO BE WEARING THE 1-DAY ACUVUE TRUEYE BRAND CONTACT LENS. ON 13JUL2016 A CALL WAS PLACED TO THE PT AND THE ADDITIONAL MEDICAL INFORMATION WAS RECEIVED AS FOLLOWS: ON (B)(6) 2016 THE PT REPORTED OD DISCOMFORT. THE PT REPORTED THAT HE/SHE WOKE UP WITH OS "WATERING, REDNESS, AND FOREIGN BODY SENSATION." THE PT REPORTED THAT THE FOLLOWING DAY AND REPORTED THAT THE OS CONTINUED TO WATER. THE PT REPORTED THAT HE/SHE DID NOT WEAR LENSES THAT DAY. THE PT REPORTED THAT ON (B)(6) 2016 THE OS CONTINUED TO WATER, BUT THE OS FELT BETTER WITH THE CONTACT LENS IN THE EYE. THE PT REPORTED THAT THE FOLLOWING DAY THE SYMPTOMS CONTINUED THE PT REPORTED THAT HE/SHE WENT TO THE EYE CARE PROFESSIONAL (ECP) AND WAS TOLD HE/SHE HAD A CORNEAL ULCER OS. ON 15JUL2016 THE PTS MEDICAL RECORDS WERE RECEIVED FROM THE PTS TREATING ECP AND THE ADDITIONAL INFORMATION WAS OBTAINED AS FOLLOWS: DATE OF VISIT: (B)(6) 2016; THE PT IS A (B)(6) FEMALE WHO RETURNS FOR A SPECIFIC PROBLEM: CONSISTENT FOREIGN BODY SENSATION AND PAIN OS X 3 DAYS; CONSISTENT TEARING OS X 3 DAYS; CONSISTENT REDNESS OS X 3 DAYS; CONSISTENT WHITE PIMPLE RUL APPROX. 1 WEEK AGO SYMPTOM RESOLVED NOW; VISION AND REFRACTION OS: PINHOLE VA, 20/200; EXAMINATION: ORBIT-LIDS-LACRIMAL: BLEPHARITIS: UPPER AND LOWER LIDS 1 + EARLY; ANTERIOR SEGMENT: CONJUNCTIVA AND SCLERA: ERYTHEMA: DIFFUSE, 1+ NO FOLLICLES; CORNEA: ULCER: 1MM; DECREASED TEAR FILM; MILD ULCER AT 6:00 WITH INTACT EPITHELIUM; ANTERIOR CHAMBER: DEEP AND QUIET; IRIS: DILATION: GOOD, NORMAL; LENS: NUCLEAR: TRACE 1+; IMPRESSION: GENERAL: ULCER: I HAVE DISCUSSED THE EXAM FINDINGS OF A CORNEAL ULCER OF THE LEFT EYE. I HAVE EXPLAINED THIS IS LIKELY DUE TO CONTACT LENS USE. D/C CONTACT LENS USE; START: ZYMAXID (OK TO SUBSTITUTE WITH VIGAMOX) Q 1 HOUR OS WHILE AWAKE UNTIL FURTHER INSTRUCTION DATE OF VISIT: (B)(6) 2016: HISTORY: PT IS A (B)(6) FEMALE WHO RETURN TO THE CLINIC FOR FU ON CORNEAL ULCER OS. THE PT WAS FIRST SEEN 1 DAY AGO. THE PROBLEM FIRST BEGAN APPROX. 3-4 DAYS AGO. THE PT HAS BEEN TREATING WITH ANTIBIOTIC DROPS. TODAY THE PT REPORTS THAT HE/SHE NOTICED BLURRED VISION IN THE AFFECTED EYE WHEN TRYING TO READ WITH PALS EARLIER TODAY. PT HAS NO OTHER COMPLAINTS TODAY; MEDS: ZYMAXID OS Q 1 HOUR; EXAM: ORBIT-LIDS-LACRIMAL: BLEPHARITIS: UPPER AND LOWER LIDS, TRACE; CONJUNCTIVA AND SCLERA: ERYTHEMA: DIFFUSE, 1+; CORNEA: ULCER: INFILTRATE: 0.5 MM; ANTERIOR CHAMBER: DEEP AND QUIET; IRIS: NORMAL; LENS: NUCLEAR: TRACE 1+; VA OS: 20/20; IMPRESSION: CORNEAL ULCER: LEFT EYE, SLOWLY WORSENING; PLAN: ULCER: I HAVE DISCUSSED THE EXAM FINDINGS OF A CORNEAL ULCER LEFT EYE. I DISCUSSED WITH THE PT ABOUT THE PRESENCE OF INFECTION WITH AN INFLAMMATORY COMPONENT. THE PT IS TO DO THE FOLLOWING: CONTINUE ZYMAXID Q 1 HOUR OS, TOMORROW Q 2 HOURS, THURSDAY Q 3 HOURS; FRIDAY Q 3 HOURS UNTIL SEEN; START LOTEMAX TID OS. DATE OF VISIT: (B)(6) 2016: HISTORY: PT IS A (B)(6) FEMALE WHO RETURN TO THE CLINIC FOR FU ON CORNEAL ULCER OS. THE PT WAS FIRST SEEN 3 DAYS AGO. TODAY THE PT HAS NO SYMPTOMS IN THE AFFECTED EYE. SINCE THE LAST VISIT THESE SYMPTOMS SEEM TO BE STABLE. THE PT DESCRIBES VISION AS OD.THE PT HAS BEEN TREATING THIS WITH ANTIBIOTIC DROPS AND STEROID DROPS. THE PT HAS NO OTHER COMPLAINTS TODAY; MEDS: LOTEMAX TID OS; ZYMAXID 1 DROP AS DIRECTED; EXAM: ORBIT-LIDS-LACRIMAL: BLEPHARITIS: UPPER AND LOWER LIDS; CONJUNCTIVA AND SCLERA: NORMAL; CORNEA: INFERIOR CORNEAL ULCER WITH NO EDEMA OR INFILTRATE, 0.5 MM SCAR; ANTERIOR CHAMBER: DEEP AND QUIET; IRIS: NORMAL; LENS: NUCLEAR 1 +; IMPRESSION: CORNEAL ULCER: LEFT EYE, SLOWLY IMPROVING; VA OS: 20/20; PLAN: MEDICATION: LOTEMAX OS STARTING SATURDAY BID, CONTINUE X 3 DAYS, THEN OD X 2 DAYS, THEN D/C; ZYMAXID OS STARTING SATURDAY QID X 3 DAYS, THEN D/C. DATE OF VISIT: (B)(6) 2016: THE PT IS A (B)(6) FEMALE WHO RETURN TO THE CLINIC FOR FU ON CORNEAL ULCER OS. THE PT WAS FIRST SEEN 3 DAYS AGO. TODAY THE PT HAS NO SYMPTOMS IN THE AFFECTED EYE. SINCE THE LAST VISIT THESE SYMPTOMS SEEM TO BE RAPIDLY IMPROVING. THE PT DESCRIBES VISION AS OD.THE PT HAS BEEN TREATING THIS WITH ANTIBIOTIC DROPS AND STEROID DROPS. THE PT HAS NO OTHER COMPLAINTS TODAY; MEDS: ZYMAXID QID OS; LOTEMAX BID OS; EXAM: ORBIT-LIDS-LACRIMAL: BLEPHARITIS: UPPER AND LOWER LIDS, TRACE; CONJUNCTIVA AND SCLERA: NORMAL; CORNEA: NO INFILTRATE, SCAR: FAINT @ 6:00; ANTERIOR CHAMBER: DEEP AND QUIET; IRIS: NORMAL; LENS: NUCLEAR 1 +; IMPRESSION: CORNEAL ULCER: LEFT EYE, RAPIDLY IMPROVING; VA OS: 20/20; PLAN: CORNEAL ULCER: I HAVE EXPLAINED TO THE PT THE EXAM FINDINGS THAT THE CORNEAL ULCER IS RAPIDLY IMPROVING. OKAY TO RESTART CL ON FRIDAY. MEDS: CONTINUE LOTEMAX 1 DROP TID AND ZYMAXID 1 DROP AS DIRECTED IN OS. NO ADDITIONAL MEDICAL INFORMATION IS EXPECTED. THE LOT NUMBER IS UNKNOWN AT THIS TIME. THE PRODUCT HAS BEEN REQUESTED FOR RETURN FOR EVALUATION, BUT IT HAS NOT YET BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. SERIOUS REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503017 1-DAY ACUVUE TRUEYE (NARA A) LENSES, SOFT CONTACT, DAILY WEAR LPL JOHNSON & JOHNSON VISION CARE, INC. ¿ US UNK-1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 69 Other| R