BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 DAY TRUEYE

    MDR report key: 1230208 · Received November 13, 2008

    Report

    Report Number
    1033553-2008-00133
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 10, 2008
    Report Date
    November 13, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THREE SEALED BLISTERS WERE RETURNED. THE PARAMETERS WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MEET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. NO OTHER VISUAL ATTRIBUTES WERE OBSERVED. THE SOLUTION WAS ALSO TESTED. THE PH AND CONDUCTIVITY WERE IN SPECIFICATION. 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.

    Description of Event or Problem · 1

    REPORTED BY ANOTHER COUNTRY'S AFFILIATE, PATIENT WAS INITIALLY REFERRED BY THE NATIONAL HEALTH SERVICE TO A PHARMACY FOR MEDICATION FOR PRESUMED CONJUNCTIVITIS OS. THE PHARMACIST DETERMINED THAT THE CONDITION WARRANTED FURTHER INVESTIGATION AND REFERRED THE PATIENT TO A GP. THE PATIENT WAS REFERRED TO AN OPHTHALMOLOGIST FOR MORE AGGRESSIVE TREATMENT. THE PATIENT WAS DIAGNOSED WITH AN ULCER AND PRESCRIBED OXAFLOXACIN Q1H THEN Q6H, PREDSOL TID, CYCLOPENTALATE TID, AND CHLORAMPHENICOL OINTMENT AT NIGHT. FOLLOW UP EXAM IN 2008 REVEALS OD CLEAR, SOME MEIBOMIANITIS, OS, 2 SMALL, LESS THAN 0.5MM INFILTRATES OR SCARS IN THE MIDPERIPHERY JUST OUTSIDE THE PULILARY MARGIN. EPITHELIUM HAS HEALED OVER WELL WITH NO STAINING. THE CORNEA IS EXPECTED TO HEAL "LEAVING VERY LITTLE EVIDENCE OF THE INFECTIVE OR INFLAMMATORY RESPONSE." THIS ULCER IS BEING REPORTED DUE TO THE AGGRESSIVE TREATMENT REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1 DAY TRUEYE SOFT CONTACT LENS LPL VISTAKON NA 1519440387

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention