BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2

    MDR report key: 6845139 · Received September 6, 2017

    Report

    Report Number
    9617710-2017-05040
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    August 4, 2017
    Report Date
    August 7, 2017
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND
    Product Code
    LPM
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2017 A PATIENT (PT) CALLED OUR AFFILIATE IN (B)(4) TO REPORT WHILE WEARING THE ACUVUE2 BRAND CONTACT LENSES HE/SHE EXPERIENCED DISCOMFORT IN BOTH EYES AFTER WEARING THE SUSPECT LENSES FOR 5-6 HOURS ON (B)(6) 2017. THE PT REPORTED HE/SHE CONTINUED TO WEAR THE SUSPECT LENSES. ON (B)(6) 2017 THE PT REPORTED REDNESS. ON (B)(6) 2017 THE PT REPORTED EYE SWELLING. THE PT WENT TO AN EYE CARE PROVIDER (ECP) ON (B)(6) 2017 AND WAS DIAGNOSED WITH KERATITIS. THE PT WAS PRESCRIBED ERYTHROMYCIN EYE OINTMENT NIGHTLY AND CHLOROMYCETIN EYE DROPS EVERY 2 HOURS. THE SUSPECT LENSES WERE REQUESTED FOR RETURN FOR EVALUATION. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. THE SUSPECT LENSES HAVE NOT BEEN RECEIVED FOR EVALUATION. THIS EVENT IS BEING REPORTED AS A WORST-CASE EVENT FOR THE PTS OS AS THE DIAGNOSIS AND TREATMENT WERE NOT VERIFIED WITH THE PTS TREATING ECP. THE EVENT FOR THE PTS OD WILL BE REPORTED IN A SEPARATE REPORT. A LOT HISTORY REVIEW WAS PERFORMED FOR LOT L003619: 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. LOT L003619 WAS PRODUCED UNDER NORMAL CONDITIONS. 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
    626860 ACUVUE 2 LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND NA L003619

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R