BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 1983886 · Received February 4, 2011

    Report

    Report Number
    1033553-2011-00009
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 4, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE. METHOD - DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT CALLED TO REPORT ANOTHER CORNEAL ULCER OR "EYE INFECTION." HE REPORTS THIS ONE IS THE SAME AS HIS PREVIOUSLY REPORTED ULCER. SEE 1033553-2009-00080. PATIENT STATES RIGHT EYE IS RED, PAINFUL, PHOTOPHOBIC AND PATIENT HAS BEEN OUT OF WORK FOR 3 DAYS. AT THE TIME OF THE CALL HE HAD NOT SOUGHT MEDICAL INTERVENTION BUT STATED INTENTION TO GO THAT DAY. THE PATIENT ADMITTED HAS BEEN SELF MEDICATING WITH MEDICINES SAVED FROM THE LAST EVENT. THE PATIENT HAS NOT RETURNED CALLS SINCE THE FIRST CALL AND ECP HAS NOT RETURNED CALLS. NO CONFIRMED INFORMATION IS AVAILABLE. THIS IS BEING REPORTED AS WORST CASE BASED ON HIS PREVIOUS INFECTIOUS ULCER. THE PATIENT WEARS LENSES EXTENDED WEAR UP TO ONE MONTH CONTINUOUSLY DESPITE WARNINGS OF THE RISK FROM ECP. PRODUCT WAS NOT RECEIVED AND NO LOT INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS DISPOSABLE SOFT CONTACT LENS LPM VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other