BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE (NARAFILCON B)

    MDR report key: 3480802 · Received November 8, 2013

    Report

    Report Number
    1033553-2013-00124
    Event Type
    Injury
    Date Received
    November 8, 2013
    Report Date
    November 11, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K100349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THREE SEALED BLISTER (S) WERE RETURNED. THE LENSES MEET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS AND DIAMETER. ONE LENS HAD AN EDGE CHIP, NO OTHER VISUAL ATTRIBUTES OBSERVED. THE SOLUTION WAS TESTED; PH WAS IN SPECIFICATION; THERE WAS NOT ENOUGH SOLUTION TO MEASURE FOR CONDUCTIVITY. A DHR WAS PERFORMED. LOT # 1255800131-OD WAS PROCESSED UNDER NORMAL MANUFACTURING CONDITIONS. THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. IF ADDITIONAL INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, AN OPTOMETRIST'S OFFICE INFORMED OUR FIRM OF A PT WHO REPORTED HAVING BEEN DIAGNOSED WITH A CORNEAL ULCER AND TREATED BY AN OPHTHALMOLOGIST. SHE WAS WEARING ACUVUE TRU-EYE CONTACT LENSES (CL) WHEN THE INJURY OCCURRED. ON (B)(6) 2013, OUR FIRM SPOKE WITH THE PT WHO STATED SHE WEARS HER GLASSES MOST OF THE TIME AND ONLY WEARS HER CONTACTS FOR SOCIAL EVENTS. THE PT WAS SEEN BY HER PRIMARY CARE PHYSICIAN WHO TOLD HER SHE THOUGHT SHE HAD "IRITIS." THE PT WAS REFERRED TO AN OPHTHALMOLOGIST AND DIAGNOSED WITH CORNEAL ULCERS OU, OS MORE SEVERE THAN OD. THE PT WAS TREATED WITH ZYMAXID Q2 X3 DAYS THEN QID, ERYTHROMYCIN HS X 7 DAYS AND LOTEMAX (TITRATED) X7 DAYS. ON (B)(6) 2013, THE TREATING OPHTHALMOLOGIST'S OFFICE STATED THE PT WAS DIAGNOSED WITH MARGINAL CORNEAL ULCERS OU. OUR FIRM HAS MADE NUMEROUS UNSUCCESSFUL ATTEMPTS TO COLLECT ADDITIONAL INFO. THE PRECISE SEVERITY OF THE REPORTED INJURY IS UNK. THIS IS BEING REPORTED AS WORST CASE. MDR #1033553-2013-00125 SUBMITTED FOR THE OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578771 1-DAY ACUVUE TRUEYE (NARAFILCON B) SOFT CONTACT LENS LPL VISTAKON NA 1255800131

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention