BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 BRAND

    MDR report key: 3541059 · Received December 16, 2013

    Report

    Report Number
    1033553-2013-00170
    Event Type
    Injury
    Date Received
    December 16, 2013
    Date of Event
    November 28, 2013
    Report Date
    December 16, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPM
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS PERFORMED. LOT L0022R8 MANUFACTURED UNDER NORMAL CONDITIONS. THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPEC. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. IF ADD'L INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY FRANCHISE MANAGEMENT REVIEW MEETINGS. DEVICE LABELING SINGLE USE OR REUSE. CONCLUSIONS - NO CONCLUSIONS CAN BE DRAWN. DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PT CONTACTED OUR (B)(4) AFFILIATE REPORTING A CORNEAL ULCER OD WHILE WEARING ACUVUE 2 CONTACT LENSES. AFTER WEARING THE FIRST PAIR OF CL FOR 10 DAYS, THE PT NOTED THE OD "BECAME VERY RED." ON (B)(6) 2013, THE PT WAS EXAMINED BY AN EYE CARE PROFESSIONAL AND DIAGNOSED WITH A CORNEAL ULCER; THE NATURE OF THE ULCER IS UNK. THE TREATMENT PLAN INCLUDED CILOXAN QHR "ON THE FIRST DAYS", THEN Q2HRS, THEN Q4HRS. ON (B)(6) 2013, THE PT STATED THE MEDICATION HAD BEEN DISCONTINUED, SHE WAS FREE OF DISCOMFORT AND WOULD RESUME LENS WEAR IN (B)(6). ON (B)(6) 2013, THE ECP'S OFFICE STATED THAT THE PT WAS FINE AND THAT SHE HAD BEEN INSTRUCTED TO USE ECOFILM LUBRICANT. BASED ON AGGRESSIVE MEDICAL TREATMENT RECEIVED, THIS EVENT IS REPORTED AS WORST CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657672 ACUVUE 2 BRAND SOFT CONTACT LENS LPM VISTAKON NA L0022R8

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other RENU LENS CARE SOLUTION