BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 1012682 · Received March 12, 2008

    Report

    Report Number
    1033553-2008-00036
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    December 27, 2007
    Report Date
    March 12, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE.

    Description of Event or Problem · 1

    THE PT CONTACTED VISTAKON 02/15/2008 PER BAUSCH AND LOMB'S RECOMMENDATION. PT REPORTED EXPERIENCING BURNING AND REDNESS OD IN 2007 AFTER ONE WEEK OF OASYS DAILY WEAR. PT REPORTED BEING TREATED WITH VIGAMOX DROPS AND INSTRUCTED TO DISCONTINUE CONTACT LENS WEAR. THE PT REPORTED RETURNING TO CONTACT LENS WEAR BEFORE BEING SEEN FOR FOLLOW UP AND INSTRUCTED TO RETURN TO CONTACT LENS WEAR. PT REPORTED THAT THE SAME SYMPTOMS RETURNED AFTER ONE WEEK OF DAILY WEAR. PT DID NOT RETURN TO DOCTOR THAT TREATED OD INITIALLY; THE PT WAS SEEN BY ANOTHER OPHTHALMOLOGIST. THE PT REPORTED USING RENU WITH MOISTURE LOC SOLUTION. THE PT ALSO REPORTED HAVING CONTACTED B&L AND WAS TOLD THAT THE SOLUTION HAD BEEN RECALLED. PT STATED THAT B&L WILL BE SENDING AN ENVELOPE TO OBTAIN THE BOTTLE OF SOLUTION. PT STATED, "I DID NOT KNOW THAT THE SOLUTION HAD BEEN RECALLED." ALSO, THAT "I COULD NOT REMEMBER HOW OLD THE SOLUTION WAS; I HAD THE BOTTLE FOR A LONG TIME BECAUSE I ONLY WEAR A CONTACT IN ONE EYE." CONTACT DETAILS FOR EYE CARE PROFESSIONAL THAT INITIALLY TREATED PT ON THAT DAY NOT AVAILABLE FROM PT. PT'S RECORD FROM SECOND OPHTHALMOLOGIST INDICATED THE FOLLOWING: 2008 - PT TOOK OUT SCL LAST NIGHT (+) BURNING, PHOTOPHOBIA, WATERING, SWOLLEN / PRESSURE FEELING DISCHARGE AND PAIN. MEDS VIGAMOX Q1.5H. BCVA OD 20/25 -. NOTE INDICATES THE CONSULTATION IS FOR CORNEAL EVAL OD AND INFECTION OD > OS. PT REPORTED SYMPTOMS STARTED YESTERDAY AT 4:30 PM WITH OD > OS RED THEN BECAME WORSE WITH PAIN AND SWELLING OF LIDS. DOCTOR NOTED 2+ CELLS IN THE OD ANT CHAMBER. OS CLEAR. ALSO NOTE WBC'S ON ENDOTHELIUM. IMPRESSION: PARACENTRAL ULCER OD. PLAN C&S FOR BACTERIA AND FUNGUS. START VANCO & FORTIFIED TOBRAMYCIN. RTC TOMORROW AM. ON 1/12/08 PT SEEN, REDUCTION IN PAIN. DRAWING INDICATES DIFFUSE INFILTRATES AND DIFFUSE EPITHELIAL EDEMA. PT HAS 2 - 3% HYPOPYON. NOTE: LOOKS BETTER, DECREASED VA SECONDARY EPITHELIAL EDEMA OD> PLAN: CONTINUE VANCO 10 MG/CC AT WITH TOBRA 14 MG/CC Q 30 MINUTES. IQUIX Q1H OD. RTN MONDAY. ON THREE DAYS LATER: PT STATES IMPROVED, BUT VA STILL DECREASED. MILD PRESSURE OD WHEN USING THE GTTS. NO PAIN. C/O STILL RED AND SWOLLEN. LITTLE PHOTOPHOBIA OD, BUT IMPROVING. NOTE INDICATES 2+ EDEMA NAD NO HYPOPYON. IMPRESSION: CORNEAL ULCER IMPROVING OD. CONTINUE MEDS. ON TWO DAYS LATER: PT STATES VA GETTING BETTER NOT AS FOGGY. STILL C/O SOME BURNING AND REDNESS. AC 2+ CELL. IMPRESSION: GREATLY IMPROVED ULCER OD. VANCO AND TOBRADEX Q1HR OD. IQUIX Q1H OD. ON SIX DAYS LATER: PT FEELS A LOT BETTER. PT STATES VA IS VERY GOOD NOW. CHART NOTES: VA 20/20 WITH CORRECTION. CORNEAL ULCER RESOLVED OD. D/C GTTS. ARTIFICIAL TEARS PRN. CULTURE & SENSITIVITY RESULTS NOT AVAILABLE. THE REMAINING PRODUCT WAS RETURNED FOR EVALUATION. FOUR SEALED BLISTERS WERE RETURNED. THE PARAMETERS OF THE LENSES WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MEET COMPANY STANDARDS FOR DIAMETER, BASE CURVE AND CENTER THICKNESS. NO VISUAL ATTRIBUTES WERE OBSERVED. THE RETURNED SOLUTION WAS TESTED. THE PH AND CONDUCTIVITY WERE WITHIN SPECIFICATION. A LOT HISTORY DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. NO ADD'L INFO IS EXPECTED TO BE RECEIVED. ALL MDRS ARE REVIEWED AT QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS SOFT CONTACT LENS LPL VISTAKON NA B0065M1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention