BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS CONTACT LENSES

    MDR report key: 1118970 · Received August 15, 2008

    Report

    Report Number
    1033553-2008-00096
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    November 9, 2007
    Report Date
    August 15, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    1-DAY ACUVUE MOIST - N18033. LABELED FOR SINGLE USE AND REUSE. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    OUR INT'L AFFILIATE REPORTS A PT DEVELOPED A CORNEAL ULCER IN THE LEFT EYE. THE PT HAD BEEN WEARING BOTH ACUVUE OASYS CONTACT LENSES AND 1-DAY ACUVUE MOIST CONTACT LENSES. THE PT REPORTEDLY SLEPT WHILE WEARING LENSES. THE REPORTING OPHTHALMOLOGIST DID NOT KNOW WHICH LENS THE PT WAS WEARING AT THE TIME OF THE INJURY. THE PT REPORTED THAT SYMPTOMS BEGAN IN 2007. THE PT CAME TO THE CLINIC IN THE NEXT DAY, AND WAS FOUND TO HAVE A 1.5MM X 2.0MM, MID-PERIPHERAL CORNEAL ULCER, OS AT 2 O'CLOCK. THERE WAS NO LOSS OF VISUAL ACUITY. THE OPHTHALMOLOGIST SUSPECTED THE CORNEAL ULCER WAS INFECTIOUS. THE OPHTHALMOLOGIST PERFORMED A CORNEAL SCRAPING AND PRESCRIBED PIMARICIN AND LEVOFLOXACIN EYE DROPS. THE CORNEAL ULCER WAS RESOLVED ABOUT ONE MONTH LATER, AND THE PT RESUMED LENS WEAR WITH 1-DAY ACUVUE MOIST CONTACT LENSES TO BE WORN LESS THAN 8 HOURS PER DAY. THE OPHTHALMOLOGIST DID NOT HAVE PRODUCT OR LOT NUMBER INFO. NO ADD'L INFO IS EXPECTED. MDR EVENTS ARE REVIEWED AT QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention