BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY TRUEYE (NARAFILCON B)

    MDR report key: 3839255 · Received May 20, 2014

    Report

    Report Number
    1033553-2014-00042
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 13, 2014
    Report Date
    May 20, 2014
    Product Code
    LPL
    PMA / PMN Number
    76466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 A PT CONTACTED OUR FIRM REPORTING HAVING EXPERIENCED A CU OS WHILE WEARING ACUVUE 1-DAY TRU EYE (NARAFILCON B) CONTACT LENSES (CL). PT REPORTED THE MORNING OF THE EVENT, SHE INSERTED A NEW LENS AND IMMEDIATELY ON INSERTION SHE EXPERIENCED BLURRY VISION BUT SHE COULD NOT REMOVE THE LENS BECAUSE SHE WAS IN A CLASS. THE PT REMOVED THE LENS 4 HRS LATER FINDING 2 LENSES STUCK TOGETHER. THE PT, WHO IS AN OPTICIAN, REPORTED PHOTOPHOBIA, WATERING, PAIN, REDNESS AND SWOLLEN EYELID AND WAS EXAMINED BY DOCTOR AT HER WORKPLACE ON (B)(6) 2014 AND DX WITH A OS CORNEAL ULCER AROUND 12 O'CLOCK THAT AFFECTED HER VISION. SHE WAS TREATED WITH VIGAMOX Q15-20 MIN X1 DAY, THEN QHR X1 DAY, THEN Q2HRS X1 AND ON DAY 3 TOBRADEX Q 2HRS WAS ADDED AND VIGAMOX CONTINUED Q 2HRS. SHE WAS EXAMINED BY THE DOCTOR EVERY DAY X5 DAYS. PT HAS COMPLETED TREATMENT AND HAS ELECTED TO WEAR GLASSES. ON (B)(6) 2014 OUR FIRM SPOKE WITH THE TREATING EYE CARE PROFESSIONAL'S STAFF WHO STATED THE PT WAS SEEN FIRST ON (B)(6) 2014 AND DX WITH A CU; PT RETURNED ON (B)(6). THE DOCTOR FELT THE CU WAS INFECTIOUS IN NATURE AND STATED THE PT HAD GRADUAL IMPROVEMENT ON RETURN VISITS AND ON 4/18 "THE ULCER WAS HEALED OVER". THE SUSPECT PRODUCT WAS DISCARDED. A 20 SEALED BLISTERS FROM THE INVOLVED CARTON WERE RETURNED TO OUR FIRM AND EVALUATED. THE PARAMETERS OF 10 LENSES WERE MEASURED AND A VISUAL INSPECTION PERFORMED. THE LENSES MEET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS AND DIAMETER. NO OTHER VISUAL ATTRIBUTES OBSERVED. THE PH IN THE SOLUTION TESTED WITHIN SPECIFICATION. THERE NOT ENOUGH SOLUTION TO MEASURE FOR CONDUCTIVITY. A DHR WAS PERFORMED; 1461470838 WAS PRODUCED UNDER NORMAL MFG CONDITIONS. THE BATCH RECORD DID NOT SHOW ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION AND STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. ADDITIONAL INFO WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298271 1-DAY TRUEYE (NARAFILCON B) SOFT CONTACT LENS LPL NA 1461470838

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention