BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND WITH HYDRACLEAR PLUS

    MDR report key: 1243720 · Received November 25, 2008

    Report

    Report Number
    1033553-2008-00135
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    January 1, 2008
    Report Date
    November 25, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A PATIENT CONTACTED OUR FIRM VIA EMAIL TO REPORT HAVING DEVELOPED AN EYE INFECTION WHILE WEARING ACUVUE OASYS CONTACT LENSES (CL). THE PATIENT REPORTED REDNESS, BLURRY VISION, ITCHING AND THAT THE EYE "CRUSTED OVER LIKE PINK EYE". THE PT STATED THAT HE/SHE STARTED WEARING ACUVUE OASYS CL THIS YEAR. THE PATIENT DID NOT INDICATE THE WEAR SCHEDULE OR THE CLEANING SOLUTION THAT HE/SHE WAS USING. THE PATIENT REPORTED HAVING BEEN TREATED BY AN EYE CARE PROFESSIONAL (ECP). THE PATIENT DID NOT PROVIDE THE ECP'S CONTACT INFORMATION. VISTAKON HAS MADE NUMEROUS UNSUCCESSFUL ATTEMPTS TO CONTACT THE PATIENT FOR ADDITIONAL INFORMATION AND RETRIEVAL OF THE SUSPECT PRODUCT. A DEVICE HISTORY REVIEW WAS NOT PERFORMED BECAUSE WE WERE NOT ABLE TO OBTAIN THE LOT NUMBER(S) FOR THE SUSPECT PRODUCT. ANY ADDITIONAL INFORMATION WILL BE REPORTED WITHIN 30 DAYS OR RECEIPT. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS BRAND WITH HYDRACLEAR PLUS SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other