BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ADVANCE PLUS BRAND W/HYDRACLEAR

    MDR report key: 2140977 · Received June 21, 2011

    Report

    Report Number
    1033553-2011-00038
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 21, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K032340
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED, NO EVALUATION CAN BE PERFORMED. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT'S (PT) SPOUSE REPORTED AN "ULCER" AND "BLINDNESS" IN THE PT OD EYE WHILE WEARING ACUVUE ADVANCE PLUS CONTACT LENS (CL). THE OPTOMETRIST REPORTED THAT ON (B)(6) 2011, THE PT PRESENTED TO THE OFFICE COMPLAINING OF "SORE" RIGHT EYE (OD). THE PT REPORTED "SLEEPING IN THE LENSES THE PREVIOUS NIGHT", AND BEING "AWAKENED BY PAIN." SLIT LAMP EXAMINATION (SLE) REVEALED 4+ ANTERIOR CHAMBER REACTION, UVEITIS, AND A CORNEAL LESION "FAIRLY LARGE" IN SIZE. OD EXAMINATION REVEALED THAT PT VISION WAS 20/40 WITH SPECTACLES AND EYE PRESSURES WERE WITHIN NORMAL LIMITS. THE OPTOMETRIST STATED THAT "THE ANTERIOR CHAMBER REACTION WAS NOT CAUSED BY CL WEAR," AND THE PT WAS REFERRED TO AN OPHTHALMOLOGIST FOR FOLLOW UP (F/U). ON (B)(6) 2011, PT VISITED AN OPHTHALMOLOGIST COMPLAINING OF PAIN, PHOTOPHOBIA AND FOGGY VISION OD SINCE (B)(6) 2011. THE PT REPORTED HAVING SLEPT IN HIS/HER CL'S FOR 1 WEEK. ACUVUE ADVANCE PLUS CL ARE NOT LABELED FOR OVERNIGHT WEAR. THE PT WAS DIAGNOSED WITH A 1.7MM INFECTIOUS CORNEAL ULCER (CU), OD, AND WAS TREATED WITH CYCLOGYL, TID AND ZYMAXID AND VIGAMOX GTTS, OD, ALTERNATING Q1HR AND INSTRUCTED TO RETURN FOR F/U THE NEXT DAY. ON (B)(6) 2011, PT F/U REVEALED CU IMPROVING. PT INSTRUCTED TO CONTINUE ALTERNATING ZYMAXID AND VIGAMOX GTTS, Q2HRS WHILE AWAKE, OD, AND CYCLOGYL GTTS DAILY, OD, UNTIL NEXT F/U. ON (B)(6) 2011, PT F/U REVEALED PTS OD "FEELS MUCH BETTER," EYE STILL RED AND PHOTOPHOBIC. THE PT WAS INSTRUCTED TO DECREASE ZYMAXID AND VIGAMOX GTTS TO QID, AND RETURN FOR F/U IN ONE WEEK. ON (B)(6) 2011, PT RETURNED FOR F/U AND WAS INSTRUCTED TO DECREASE ZYMAXID AND VIGAMOX GTTS TO TID AND RETURN FOR FOLLOW UP IN ONE WEEK. ON (B)(6) 2011, PT'S SPOUSE REPORTED THAT PT "EYE IS HEALING" AND THAT PT HAS SCARRING BUT IS SCHEDULED TO BE REFITTED BACK INTO CL AND HAS F/U VISIT (B)(6) 2011. THE LOT NUMBER IN QUESTION IS UNK. THE PRODUCT IN QUESTION HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. THE REMAINING PRODUCT HAS BEEN REQUESTED. A LOT HISTORY REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE ADVANCE PLUS BRAND W/HYDRACLEAR SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other OPTIFREE SOLUTION