BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE

    MDR report key: 1230207 · Received November 13, 2008

    Report

    Report Number
    1033553-2008-00132
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    September 21, 2008
    Report Date
    November 13, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RECEIVED INFORMATION FROM ANOTHER COUNTRY. PATIENT REPORTEDLY WAS FIT WITH 1-DAY ACUVUE AFTER HAVING PREVIOUSLY WEARING A 1 MONTH REPLACEMENT DAILY WEAR LENS. THE PATIENT PRESENTED WITH A CORNEAL ULCER OS WHICH WAS CULTURED POSITIVE FOR STAPH AUREUS. THE PATIENT FOLLOWED UP WITH THE OPHTHALMOLOGIST IN 2008. EXAM RESULTS VA OF 6/6 (20/20) AND A SCAR UNDER THE LEFT PUPIL. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1-DAY ACUVUE SOFT CONTACT LENS LPL VISTAKON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R