BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND CONTACT LENS

    MDR report key: 4223281 · Received October 29, 2014

    Report

    Report Number
    1033553-2014-00096
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 29, 2014
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED, UNABLE TO CONFIRM COMPLAINT, DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A PATIENT (PT) CONTACTED OUR FIRM TO REPORT A CORNEAL ULCER WHILE WEARING ACUVUE OASYS CONTACT LENS OS. THE PT HAS WORN THE OASYS CONTACT LENS FOR MANY YEARS. THE PT REPORTS THAT SHE WORE THE LENS DAILY AND HAD A TWO WEEK REPLACEMENT SCHEDULE. THE PT ADVISED THAT "AFTER LESS THAN 10 DAYS WEARING THIS PAIR STARTED TO FEEL BURNING, PAIN, OCULAR HYPEREMIA, AND PHOTOPHOBIA ON LEFT EYE (OS)". THE PT WENT TO HIS/HER EYE CARE PROFESSIONAL (ECP) WHO CLASSIFIED IT AS AN "INFECTIOUS CORNEAL ULCER SMALLER THAN 1 MM SIZE, INFERIOR, POSITION OF 6 O'CLOCK IN THE CORNEA WITH INFLAMMATORY INFILTRATE AND ANTERIOR CHAMBER REACTION. TREATMENT RECOMMENDED DURING THE FIRST DAY: EYE DROP VIGAMOX 1 DROP EACH HOUR. PT DO NOT EXCHANGE THE SOLUTION DAILY AND THE CASE IS MORE THAN 3 MONTHS OLD. PRODUCT NOT AVAILABLE. LOT NUMBER NOT AVAILABLE". THE PT WAS SEEN FOR FOLLOW-UP ON 10/04/2014. THE CORNEAL ULCER WAS NOTED TO BE LOCALIZED AT 6 O'CLOCK IN THE CORNEA, AT ABOUT 2-3 MM FROM THE LIMBUS, 3 MM AWAY FROM THE PUPIL AXIS. IT'S SIZE WAS SMALLER THAN 1 MM DIAMETER". "THE EPITHELIAL EROSION WAS HEALED, AND SHE PRESENTED ONLY WITH EPITHELIAL EDEMA SURROUNDING THE LESION, ALMOST WITHOUT ANTERIOR CHAMBER REACTION, AND NO PAIN ANYMORE". ON (B)(6) 2014, THE PT RETURNED TO THE ECP AND SHE ADVISED THAT THE "LESION WAS SCARED WITH NO INFILTRATE OR INFECTIOUS ASPECT". THERE WAS AN AREA WITH KERATITIS BOTH NASAL AND TEMPORAL AREAS (ONLY LEFT EYE OS). THE PT WAS PRESCRIBED HYABAK, 1 DROP FOUR-FIVE TIMES PER DAY, DURING WEEK 1". ON (B)(6) 2014, THE PT HAD A FOLLOW-UP APPOINTMENT WITH HIS/HER ECP. THE PT STATES THAT HIS/HER EYE IS FINE AND HE/SHE CAN RETURN TO CONTACT LENS WEAR. THE ECP REFIT THE PT FOR ACUVUE 1-DAY TRUEYE CONTACT LENS. ANY ADDITIONAL INFO WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. SERIOUS REPORTABLE EVENTS TRENDS ARE REVIEWED IN QUARTERLY MANAGEMENT FRANCHISE REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691321 ACUVUE OASYS BRAND CONTACT LENS SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention