BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS DAILIES TORIC

    MDR report key: 3865490 · Received May 28, 2014

    Report

    Report Number
    9610813-2014-00010
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    February 23, 2014
    Report Date
    May 1, 2014
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K050065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THE COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. RETAINED PRODUCT FROM THE SAME LOT WAS EVALUATED AND ALL TESTING WAS FOUND TO BE WITHIN SPECIFICATION. THERE WERE NO NON-CONFORMITIES OR DEVIATIONS DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EYE CARE PROFESSIONAL (ECP) THAT A PATIENT WAS SEEN FOR AN ULCER IN THE LEFT EYE AND THINKS IT MAY BE CONTACT LENS RELATED. ADDITIONAL INFORMATION RECEIVED FROM THE TREATING ECP ON (B)(6) 2014, STATING THAT THE PATIENT WAS DIAGNOSED WITH A CENTRAL BACTERIAL CORNEAL ULCER, 0.5MM IN SIZE, IN THE LEFT EYE ON (B)(6) 2014. THE PATIENT EXPERIENCED MODERATE PAIN/DISCOMFORT, MODERATE REDNESS, WATERY DISCHARGE, A MILD ANTERIOR CHAMBER REACTION, AND MODERATE STAINING OVER LESS THAN 50% OF THE CORNEA. ONE CENTRAL INFILTRATE, 0.5MM IN SIZE, WAS PRESENT, AND PERMANENT SCARRING WAS NOTED. THE PATIENT WAS PRESCRIBED VIGAMOX, EVERY 30 MINUTES IN THE LEFT EYE, ALTERNATING WITH TOBRAMYCIN GTT EVERY 30 MINUTES AND ERYTHROMYCIN UNG QHS AND HOMATROPINE 2% BID. FOLLOW UP WAS SCHEDULED FOR (B)(6) 2014, AND THEN EVERY FEW DAYS. THE BEST CORRECTED VISUAL ACUITY PRIOR TO AND AFTER THE EVENT WAS 20/20. THE EVENT HAS RESOLVED AND LENS WEAR HAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314202 FOCUS DAILIES TORIC LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH N0528180

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other