BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ADVANCE FOR ASTIGMATISM

    MDR report key: 1080380 · Received July 21, 2008

    Report

    Report Number
    1033553-2008-00080
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 22, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K032340
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT CALLED 2008 TO REPORT BEING DIAGNOSED WITH AN INFECTIOUS CORNEAL ULCER IN THE LEFT EYE WHILE WEARING ACUVUE ADVANCE FOR ASTIGMATISM LENSES. THE PT REPORTED BEING PLACED IN THE PRODUCT IN THREE MONTHS EARLIER, WAS TRIAL FIT FOR ONE MONTH PRIOR TO PURCHASE AND INSTRUCTED BY THE PRESCRIBING EYE CARE PROFESSIONAL TO WEAR THE LENSES ON A DAILY WEAR SCHEDULE FOR ONE MONTH AT A TIME. THE PT REPORTED INITIALLY EXPERIENCING PAIN IN THE LEFT EYE PROMPTING THE NEED TO SEEK MEDICAL INTERVENTION. THE TREATING OPHTHALMOLOGIST REPORTED INITIALLY SEEING THE PT THREE DAYS PRIOR TO ORIGINAL DATE, AND NOTED AN INFERIOR-NASAL BACTERIAL ULCER TO THE CENTER OF THE VISUAL AXIS. DOCTOR REPORTED THAT THE PT'S VISUAL ACUITY WAS INITIALLY COUNTING FINGERS ONLY AND IS CURRENTLY 20/250 WITH CORRECTION. DOCTOR REPORTED THAT A CULTURE WAS TAKEN BUT THE RESULTS WERE INCONCLUSIVE. DOCTOR ALSO CONFIRMED THAT THE PT HAD ALSO BEEN RINSING THE LENSES WITH TAP WATER PRIOR TO DEVELOPING THE INFECTIOUS ULCER. THE PT WAS TREATED WITH VIGAMOX GTTS ONE DROP Q1HR AND POLYTRIM GTTS. FOLLOW UP VISIT THE FOLLOWING MONTH, DOCTOR NOTED THAT THE ULCER WAS "GREATLY IMPROVED" THE PT'S VISUAL ACUITY WAS 20/40 WITHOUT CORRECTION; THE PT DID NOT HAVE A PAIR OF GLASSES IN A CURRENT PRESCRIPTION. THE PT WAS INSTRUCTED TO RETURN TO THE PRIMARY EYE CARE PROFESSIONAL BEFORE RETURNING TO CONTACT LENS WEAR. NO ADDITIONAL INFO WAS AVAILABLE AND NO FURTHER INFO IS EXPECTED TO BE RECEIVED. THE PT DISCARDED THE PRODUCT IN QUESTION. A LOT HISTORY REVIEW INDICATED THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPEC. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. ALL REPORTABLE ADVERSE EVENTS ARE REVIEWED IN QUARTERLY MGMT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE ADVANCE FOR ASTIGMATISM SOFT CONTACT LENS LPL VISTAKON NA B005950

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention