BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS WITH HYDRACLEAR

    MDR report key: 1419265 · Received July 22, 2009

    Report

    Report Number
    1033553-2009-00055
    Event Type
    Injury
    Date Received
    July 22, 2009
    Date of Event
    June 23, 2009
    Report Date
    July 22, 2009
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN QUESTION HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR EVAL. THE LOT HISTORY RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPEC. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. ADD'L INFO IS EXPECTED; WILL REPORT ANY ADD'L INFO WITHIN 30 DAYS UPON RECEIPT. ALL MDR REPORTS ARE REVIEWED AT QUARTERLY MANAGEMENT REVIEW MEETINGS. NO CONCLUSION CAN BE DRAWN. DEVICE DISCARDED-UNABLE TO FOLLOW UP.

    Description of Event or Problem · 1

    PT CALLED 06/24/2009 TO REPORT BEING DIAGNOSED WITH A CORNEAL ULCER IN THE RIGHT EYE (OD) IN 2009. PT REPORTED INITIALLY EXPERIENCING PAIN SEVERAL HOURS AFTER INSERTING A NEW LENS OD ABOUT 2 DAYS PRIOR. PT STATED THAT AFTER REMOVING THE LENS THAT AFTERNOON, "NOTICED WHITE DOT ON MY CORNEA." CHART FROM TREATING OPHTHALMOLOGIST CONFIRMED THAT THE PT PRESENTED ON THE DAY OF THE EVENT WITH C/O "BLOOD SHOT OD-WHITE SPECK ON CORNEA STARTED SUNDAY- HAS NOT WORN CL SINCE. +LIGHT SENSITIVE. SWITCHED ACUVUE LENSES TO OASYS. NOT SLEEPING IN LENSES. VA WITH CORRECTION: OD 20/30+2 OS 20/25+2. AT 1+INJECTION OD. AT 2MM BACTERIAL SUPERIOR ULCER OD SPK OS. RARE CELL OD ONLY. ZYMAR Q1HRX6H THEN Q2H THEN BID TOBRADEX Q2HR. NO CL WEAR. "F/U IN THE NEXT DAY: "VA WITH CORRECTION OD 20/30+2 OS 20/25. DECREASED INJECTION OD. AC RARE CELL OD. DECREASED CORNEAL ULCER OD. ZYMAR Q2HRS OD, TOBRADEX QID. "F/U AT ABOUT 2 DAYS LATER: "VA WITH CORRECTION OD 20/20-2 OS 20/25-1. NEG EDEMA OU. NEG STAINING OD. ABOUT 20% IMPROVED CORNEAL ULCER. RARE CELL OD. CORNEAL ULCER OD. DECREASED INFILTRATES OD. IMPROVED OD. ZYMAR Q3HRS OD X24 HRS EVERY 4 HOURS AFTER THAT. CONTINUE TOBRADEX QID OD. F/U 3 DAYS." "VA WITH CORRECTION OD 20/30-1 OS 20/30-2. DECREASED 50% CORNEAL ULCER OD. MILD DRYNESS OU. VERY RARE CELL OD. ZYMAR 6X OD, TD 4XOD, AT QD TO BID OU." F/U ONE WEEK LATER: "VA OD 20/30+2, OS 20/20+2. DECREASED 65-70% ULCER OD, NEG INFILTRATE. DECREASED CORNEAL ULCER, INFILTRATES OD. DRYNESS OU. CONT. ZYMAR 6X OD, TD 4X OD, AT BID OU. RETURN 1 WEEK." F/U AT 8 DAYS INDICATES: "NEG SYMPTOMS, DECREASED OD. NEG ACTIVE INFECTION. NEG STINGING OD. AC- VERY RARE CELL OD. DECREASE CORNEAL ULCER OD. DRYNESS OU. ZYMAR OD DECREASED TO 5X DAY, TOBRADEX 3X DAY OD, AT BID OU. RTC PRN OR 2 WEEKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS WITH HYDRACLEAR SOFT CONTACT LENS LPL VISTAKON NA 2128710182

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention