BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESHLOOK ONE-DAY

    MDR report key: 2470470 · Received February 24, 2012

    Report

    Report Number
    9610813-2012-00001
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 25, 2012
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K050213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RECEIVED BY THIS MFR, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, A FOLLOW-UP MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY A PT'S COLLEAGUE THAT THE PT WAS DIAGNOSED WITH A CORNEA EDEMA WITH INFLAMMATION IN HER RIGHT EYE. THE PT REPORTED THAT THEY DID NOT RECEIVE ANY INSTRUCTIONS FOR USE FROM THE OPTICIAN WHEN THE CONTACT LENSES WERE PURCHASED. TREATMENT PRESCRIBED WAS REPORTED AS TOBREX AND CILOXAN OPHTHALMIC DROPS 8 DROPS PER DAY. ADD'L INFO RECEIVED FROM THE PT'S COLLEAGUE (B)(6) 2012. THE FIRST USE OF THE CONTACT LENS BY THE PT WAS ON (B)(6), 2011. AFTER THE FIRST WEAR, SHE HAS REMOVED THE LENS AND PUT IT ON A HANDKERCHIEF FOR ONE MONTH. ON (B)(6), 2012, SHE REUSED THE CONTACT LENS WITH DIRTY FINGERS AND DID NOT USE ANY LENS CARE SOLUTION DURING THE MONTH. THE SAME DAY, SHE WENT TO HOSPITAL BECAUSE SHE EXPERIENCED RED EYE ON RIGHT ONE. SHE WAS DIAGNOSED WITH CORNEA EDEMA, CORNEAL ULCER, AND ANTERIOR CHAMBER INFLAMMATION. EXTENDED CORNEA HYPOXIA WAS NOTED. THE EYE CARE PROFESSIONAL CONCLUDED THAT THIS IS THE RESULT OF MISUSE BY THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESHLOOK ONE-DAY LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH N0215307

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other