BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND CONTACT LENSES

    MDR report key: 4112868 · Received September 17, 2014

    Report

    Report Number
    1033553-2014-00082
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 17, 2014
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. PRODUCT WAS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS EXPECTED. IF ADDITIONAL INFORMATION RECEIVED, WILL SUBMIT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A PATIENT (PT) CONTACTED OUR FIRM VIA EMAIL REPORTING HAVING EXPERIENCED AN OCULAR EVENT WHILE WEARING ACUVUE OASYS CONTACT LENSES (CL). THE PATIENT WAS WEARING THE LENSES ON A DAILY WEAR AND MONTHLY REPLACEMENT SCHEDULE AND WAS USING OPTI-FREE LENS CARE SOLUTION. THE PATIENT REPORTED THAT ON (B)(6) 2014, HE/SHE "WORE THE FIRST PAIR OF ACUVUE OASYS CONTACT LENSES TWO WEEKS AGO, AND AFTER TWO WEEKS OF USE" BOTH EYES WERE VERY RED AND PAINFUL. THE PATIENT WAS SEEN BY A DOCTOR THE SAME DAY AND DIAGNOSED WITH A CORNEAL ULCER (CUR) OS. THE PATIENT WAS TREATED WITH OTPIVE Q 3 HRS AND ZYMAR Q 2 HRS X1 WEEK OU AND CL WERE DISCONTINUED DURING TREATMENT. ON (B)(6) 2014 OUR FIRM SPOKE WITH THE TREATING ECP WHO STATED HE/SHE SAW THE PATIENT IN THE EMERGENCY ROOM ON (B)(6) 2014 AND SLIT LAMP EXAM REVEALED OS BULBAR HYPEREMIA AND CU LESS THAN 1 MM PERIPHERALLY LOCATED OUT OF THE VISUAL AXIWS AND PRESCRIBED ZYMAR Q 2HRS OS X 7 DAYS; THE CU WAS CONSIDERED TO BE INFECTIOUS IN NATURE. THE OD WAS CLEAR AND WHEN THE DOCTOR WAS ASKED WHY THE PATIENT WAS BEING TREATED IN THE OTHER EYE HE/SHE STATED "THAT PROBABLY THE PATIENT IS USING THE OTHER EYE BY MISTAKE" BECAUSE IT WAS NOT THE DOCTOR'S RECOMMENDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575880 ACUVUE OASYS BRAND CONTACT LENSES DISPOSABLE SOFT CONTACT LENS LPL NA L00286C

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other| R OPTI FREE LENS CARE SOLUTION