BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND

    MDR report key: 3893614 · Received June 9, 2014

    Report

    Report Number
    1033553-2014-00045
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    February 27, 2014
    Report Date
    June 9, 2014
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS PERFORMED. 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. NO ADDITIONAL INFORMATION IS EXPECTED. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A PATIENT (PT) REPORTED HAVING EXPERIENCED RECURRENT OCULAR ISSUES OD WHICH INCLUDED A CORNEAL ULCER (CU) WHILE WEARING ACUVUE OASYS CONTACT LENSES (CL). THE PT STATED HE/SHE WAS WEARING CL ON DAILY WEAR AND BIWEEKLY REPLACEMENT SCHEDULE AND USING OPTI-FREE LENS CARE SOLUTION. THE PT HAD WORN OASYS LENSES FOR ABOUT 5 YEARS AND STARTED EXPERIENCING RECURRENT ISSUES WITH A CARTON FROM THE MOST RECENT SUPPLY. ON (B)(6), OUR FIRM SPOKE WITH THE TREATING DOCTOR'S OFFICE WHO STATED THEY SAW THE PT FOR THE FIRST TIME ON (B)(6) 2014. HE/SHE WAS DX WITH KERATITIS OD AND TREATED WITH TOBRADEX DROPS Q3HRS AND INSTRUCTED NOT TO WEAR CL FOR 2 WEEKS. ON (B)(6) 2014, PT RETURNED FEELING MUCH BETTER AND WAS INSTRUCTED TO D/C TOBRADEX AND USE ARTIFICIAL TEARS; NO CL FOR 2 WEEKS. ON (B)(6) 2014, PT RETURNED C/O OD PROBLEM RECURRED, SLE REVEALED CU AT 09:30; THE TREATMENT REGIMEN INCLUDED VIGAMOX Q3HRS X1 WEEK AND NO CL USE. ON (B)(6) 2014, FU CORNEAL SCAR AT 0900, USE ARTIFICIAL TEARS AND NO CL X1 MONTH. ON (B)(6) 2014, PT RETURNED C/O PAIN AND LIGHT SENSITIVITY AND WAS DX RECURRING CU AND INSTRUCTED TO USE TOBRADEX Q2HRS X1 DAY THEN Q4X1 WEEK. ON (B)(6) 2014, F/U CORNEA CLEAR, NO CL 2 WKS, D/C TOBRADEX. PT WAS GIVEN TRIALS OF COMPETITIVE BRAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334352 ACUVUE OASYS BRAND DISPOSABLE SOFT CONTACT LENS LPL VISTAKON NA B00GHRM

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR OPTI FREE