BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE MULTI-ACTION UNIT DOSE SOLUTION

    MDR report key: 3221026 · Received May 21, 2013

    Report

    Report Number
    1610287-2013-00024
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ALCON - KAYSERSBERG FRANCE
    Product Code
    LPN
    PMA / PMN Number
    P830034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT HAS NOT BEEN REC'D FOR EVAL. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. NO ROOT CAUSE COULD BE DETERMINED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPTICIAN REPORTED A PT WHO EXPERIENCED A CORNEAL ULCER WITH ABSCESS FORMATION FOLLOWING THE USE OF THIS PRODUCT. THE PT HAD WORN THE SAME TYPE CONTACT LENSES FOR APPROX TWO YRS. WHILE WEARING THESE LENSES AND USING THIS PRODUCT, THE PT BEGAN EXPERIENCING A DISTURBANCE UNDER THE LENS. AN ABSCESS WAS DIAGNOSED UNDER THE RIGHT EYE. THE PT FELT INTENSE PAIN. NO ANTERIOR CHAMBER REACTION WAS NOTED. THE SYMPTOMS PERSISTED FOR ONE WEEK. THE PT COULD NOT WEAR HER CONTACT LENSES DURING THIS TIME. THE PT WAS TREATED WITH ANTIBIOTIC AND LUBRICATING DROPS. THE OPTICIAN REPORTED THE PT'S PROGNOSIS WAS STABLE WITH GOOD VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226175 OPTI-FREE MULTI-ACTION UNIT DOSE SOLUTION LENS CARE DISINFECTING SOLUTIONS LPN ALCON - KAYSERSBERG FRANCE NA 11220A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention AIR OPTIX MULTIFOCAL CONTACT LENSES FOR THE PAST| TWO YRS