BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND

    MDR report key: 1180450 · Received September 26, 2008

    Report

    Report Number
    1033553-2008-00112
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    August 9, 2008
    Report Date
    September 26, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2008, A PT INFORMED US THAT HE/SHE SAW A DOCTOR DUE TO OS REDNESS AND WAS DIAGNOSED WITH "PINK EYE". THE PT WAS TREATED WITH GENTAMICIN SULFATE 0.3%. ON TWO MONTHS EARLIER, THE PT SAW AN EYE CARE PROFESSIONAL (ECP) DUE TO OS LID EDEMA AND WATERING. SLIT LAMP EXAM WAS -CELLS AC, +CONJUNCTIVAL INJECTION AND CORNEAL INFILTRATES. THE PT WAS DIAGNOSED WITH PANNUS AND THE VA WAS 20/20 AT THAT TIME. THE PT WAS TREATED WITH CILOXIN ONE DROP EVERY 2 HOURS AND INSTRUCTED TO STOP WEARING CONTACT LENSES (CL) FOR A WHILE. THE ECP STATED THAT ON FOUR DAYS LATER, THE OS WAS 60-70% BETTER AND THE PT WAS INSTRUCTED TO DECREASE CILOXIN TO QID, VA 20/20. THE PT RETURNED TO THE CLINIC ON A MONTH PRIOR TO ORIGINAL DATE STATING THAT HE/SHE THOUGHT SHE MIGHT BE ALLERGIC TO CL AS THE PT HAD BEEN EXPERIENCING SYMPTOMS SINCE SWITCHING TO ACUVUE OASYS CL. THE OS WAS "VERY PINK" WITH A LARGE AMOUNT OF WATERING AND LIGHT SENSITIVITY, VA 20/20-1. THE PT WAS DIAGNOSED WITH A PERIPHERAL CORNEAL ULCER THAT THE ECP FELT WAS INFECTIOUS IN NATURE. THE PT WAS TOLD TO DISCONTINUE WEARING CL FOR 6 WEEKS AND TREATED WITH VIGAMOX EYE DROPS EVERY 2 HOURS; CILOXIN WAS DISCONTINUED. ON THREE DAYS LATER, THE PT WAS FEELING BETTER, WITH DECREASED OS REDNESS, AND PAIN. VIGAMOX WAS CHANGED TO 4 TIMES A DAY AND THE VA IN THE OS WAS 20/20. THE PT RETURNED TO THE CLINIC ON ORIGINAL MONTH. LIMBAL INFILTRATES WERE OBSERVED ON EXAM AND THE OS WAS FEELING BETTER. THE PT WAS INSTRUCTED TO CONTINUE VIGAMOX EYE DROPS FOUR TIMES A DAY AND RETURN TO THE CLINIC IN ONE WEEK, VA 20/20. THE ECP STATED THAT THE PT WAS LAST SEEN ON EIGHT DAYS LATER, ASYMPTOMATIC AND TRIAL FIT IN A DIFFERENT PRODUCT. THE PRODUCT WAS REQUESTED FROM THE PT BUT WAS NOT RECEIVED. A DEVICE HISTORY REVIEW WAS PERFORMED. THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. ALL MDR EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS BRAND SOFT CONTACT LENS LPL VISTAKON NA 2127760485

    Patients

    Seq Age Sex Outcome Treatment
    1 Other