BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 1180456 · Received September 26, 2008

    Report

    Report Number
    1033553-2008-00113
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 26, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT CONTACTED OUR FIRM BY EMAIL TO REPORT CORNEAL ULCER BUT HAS NOT RESPONDED TO REQUESTS FOR INFO. CALLED REFERRING PHYSICIAN AND RECEIVED MEDICAL INFO. REFERRAL PHYSICIAN HAS NOT RESPONDED TO REQUEST FOR INFO. PT SEEN IN 2008 AND FIT FOR AOFA LENSES. PT HAS NOT WORN CL'S FOR SEVERAL YEARS. FIT WAS GOOD AND PT WAS COMFORTABLE. ON THE FOLLOWING MONTH, PT PRESENTED WITH PAIN AND REDNESS. EXAM REVEALED CENTRAL CORNEAL DEFECT. INITIALLY THE OPTOMETRIST WAS UNSURE IF DEFECT WAS ABRASION, OR HERPETIC EROSION VS. ULCER. TREATMENT WAS STARTED WITH IQUIX Q1H. ON THE NEXT DAY, THE PT RETURNED FOR FOLLOW UP AND WAS NO BETTER, POSSIBLY WORSE. THE PT WAS REFERRED TO A CORNEAL SPECIALIST. REPORT FROM THE OPHTHALMOLOGIST RECEIVED BY THE OPTOMETRIST STATES THE PT PRESENTED WITH RED EYE, PAIN AND PHOTOPHOBIA. VA UNCORRECTED OD 20/40, OS 20/200 PH OS 20/50. 2-3+ CONJUNCTIVAL INJECTION. DX CENTRAL CORNEAL ULCER. A/C OD DEEP AND QUIET, OS 2+ CELLS AND FLARE. CORNEA WAS DEBRIDED, RX CYCLOGYL, DECREASED IQUIX FREQUENCY. IF ADDITIONAL INFO 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 ACUVUE OASYS SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R