BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 4112592 · Received September 10, 2014

    Report

    Report Number
    9610813-2014-00033
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 18, 2014
    Manufacturer
    CIBA VISION GMBH
    Product Code
    LPL
    PMA / PMN Number
    K1131168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVALUATION. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    AS INITIALLY REPORTED BY AN EYE CARE PROFESSIONAL ON (B)(6) 2014, A PATIENT EXPERIENCED IRRITATION WITH CONTACT LENSES. FURTHER INFO RECEIVED BY THE EYE CARE PROFESSIONAL ON (B)(6) 2014 CLARIFIED BOTH THE EVENT AND THE DIAGNOSIS AS MICROBIAL KERATITIS WITH THE PRESENCE OF A PERIPHERAL CORNEAL ULCER IN THE RIGHT EYE, PER EXAMINATION FINDINGS ON (B)(6) 2014. THE PATIENT EXPERIENCED SYMPTOMS OF SEVERE PAIN/DISCOMFORT, MODERATE REDNESS, AND A WATERY DISCHARGE FROM THE RIGHT EYE. ADDITIONAL PHYSICAL EXAM FINDINGS SHOWED MODERATE CORNEAL STAINING (<50%), NO ANTERIOR CHAMBER REACTION, AND NO CHANGE IN A BEST CORRECT VISUAL ACUITY OF 20/20 PRIOR TO AND AFTER THE EVENT. THE PATIENT WAS PRESCRIBED VIGAMOX EYE DROPS FOR AN UNSPECIFIED AMOUNT OF TIME AND WAS INSTRUCTED TO NOT RESUME CONTACT LENS WEAR DURING THE COURSE OF TREATMENT FOR THIS EVENT. IT HAS BEEN CONFIRMED BY THE EYE CARE PROFESSIONAL THAT THE EVENT HAS RESOLVED AND THAT THE PATIENT HAS CONTINUED WITH CONTACT LENS WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559787 DAILIES TOTAL 1 LENS, CONTACT (DISPOSABLE) LPL CIBA VISION GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other