BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 4708230 · Received April 20, 2015

    Report

    Report Number
    1033553-2015-00019
    Event Type
    Injury
    Date Received
    April 20, 2015
    Date of Event
    July 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ? US
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE RECEIVED A COPY OF THE MEDICAL RECORD ON 08APR2015 WHICH PROVIDED THE FOLLOWING INFORMATION: (B)(6) 2012: PT CAME TO THE EYE CARE PROFESSIONAL¿S (ECP) OFFICE. CHIEF COMPLAINT: EYES BURNING AND LIGHT SENSITIVE. PT¿S UNAIDED VA OD 20/800. PRIOR UNAIDED VA OD 20/300. THE ECP NOTED THE FOLLOWING SIGNS FROM THE EXAM: LIDS:¿BLEPH +1 OU; CONJ: BULBAR: CONJUNCTIVAL EDEMA GR3, OD, OS NORMAL; PALPEBRAL: WHITE & CLEAR OU; CORNEA: OD: ULCER ~10:30 O/C +NAFL ~1MM SIZE; STROMA: NORMAL; ENDOTHELIUM: CELLS ON BACK SURFACE; TEAR FILM: NORMAL. ANTERIOR CHAMBER: CELLS 2+ NO HYPOPYON; FLARE 1+. DX: ULCER, CORNEAL MARGINAL; CORNEAL EDEMA ¿ CONTACT RELATED; IRIDOCYCLITIS, ACUTE & SUBACUTE UNSPECIFIED.¿ RX: CYCLOPENTOLATE 1% BID; PRED FORTE 1% Q2H WAKING HOUR; MOXEZA (0.5% SOL) Q2H WAKING HOUR; NO CL WEAR. RTN 2 DAYS FOR F/U. (B)(6) 2012: PT RTC. ULCER F/U & IRITIS F/U. VA WITH CORRECTION: OD 20/20. EXAM FINDINGS: ¿LIDS: BLEPH 1+ OU; CONJ: BULBAR: NORMAL; PALPEBRAL: WHITE & CLEAR; CORNEA OD: EPITHELIUM: OPACITY ~10:30 O/C ~1MM, NO STAIN. STROMA: NORMAL; ENDOTHELIUM: CELLS ON BACK SURFACE; TEAR FILM: NORMAL; ANTERIOR CHAMBER: TRACE CELLS; NO FLARE. DIAGNOSIS: CORNEAL OPACITY: PERIPHERAL; IRIDOCYCLITIS, ACUTE & SUBACUTE, UNSPECIFIED. PLAN: ULCER IMPROVED TO NOW JUST AN OPACITY OD, TAPER MOXEZA OD QID X 4 DAYS THEN STOP. NO CL WEAR; IRITIS IMPROVED OD, STOP CYCLOPENTOLATE. TAPER PA(SIC) 1% QID X 4 DAYS, BID X 4 DAYS, THEN QD X 4 DAYS, THEN STOP. RTN IN 12 DAYS.¿ (B)(6) 2012: PT RTC FOR F/U. VA OD WITH CORRECTION: 20/20. EXAM: ¿LIDS: NO ABNORMALITIES; CONJ: BULBAR & PALPEBRAL: WHITE & CLEAR; CORNEA: OPACITY ~10:30 O/C ~1MM SIZE, NO STAIN; STROMA: NORMAL; ENDOTHELIUM: NORMAL; TEAR FILM: NORMAL. ANTERIOR CHAMBER: NO CELLS/ NO FLARE. DX: CORNEAL OPACITY: PERIPHERAL; IRIDOCYCLITIS, ACUTE AND SUBACUTE, UNSPECIFIED. PLAN: OPACITY REMAINS OD, OK TO WEAR CL AGAIN. IRITIS: QUIESCENT OD; STOP TAPER. OK TO WEAR CL AGAIN.¿ THE PRACTICE WHERE THE PATIENT WAS TREATED WAS CONTACTED FOR LOT# INFORMATION; WE LEARNED THE LOT# WAS NOT DOCUMENTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 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. (B)(4).

    Description of Event or Problem · 1

    ON 23MAR2015 OUR COMPLAINT HANDLING DEPARTMENT RECEIVED AN EMAIL FROM OUR FIRM¿S MEDICAL AFFAIRS DEPARTMENT INDICATING THAT A PATIENT (PT) ENROLLED IN A COMPANY SPONSORED REGISTRY WAS FOUND TO HAVE A CONTACT LENS PERIPHERAL ULCER OR POSSIBLE MICROBIAL KERATITIS ASSOCIATED WITH A NON-STUDY CONTACT LENS: ACUVUE OASYS BRAND CONTACT LENS. THE PT WAS ENROLLED IN A COMPANY SPONSORED REGISTRY ((B)(6) REGISTRY) AS A WEARER OF THE 1-DAY ACUVUE MOIST BRAND CONTACT LENSES BUT HAD SWITCHED BACK TO HIS/HER ORIGINAL LENS TYPE, ACUVUE OASYS, AT THE TIME OF THIS EVENT. BECAUSE THIS PATIENT HAD BEEN PART OF THE REGISTRY, THE CASE WAS ADJUDICATED BY THREE CLINICAL EXPERTS AT THE END OF THE REGISTRY. THE DIAGNOSIS BY RECORD REVIEW, WHICH WAS SUBSEQUENTLY DOCUMENTED IN THE STUDY REPORT, WAS CONTACT LENS PERIPHERAL ULCER/POSSIBLE MK. THE PRINCIPAL INVESTIGATOR RECEIVED THE MEDICAL RECORD PERTAINING TO THIS EVENT ON (B)(6) 2012. OUR COMPLAINT HANDLING UNIT BECAME AWARE OF THIS EVENT ON 23MAR2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259757 ACUVUE OASYS LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ? US UNK-PH

    Patients

    Seq Age Sex Outcome Treatment
    1 53 Other| R