BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE EVERMOIST

    MDR report key: 2113759 · Received June 2, 2011

    Report

    Report Number
    1610287-2011-00052
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K102860
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A PATIENT DEVELOPED AN EYE INFECTION IN THE RIGHT EYE (OD) FOLLOWING USE OF THIS PRODUCT. THE PATIENT WAS TREATED BY AN OPHTHALMOLOGIST WITH ANTIBIOTICS FROM (B)(6) 2011 UNTIL (B)(6) 2011. THE OPTOMETRIST REPORTED THE PATIENT'S VISION WAS 20/20 OD WITH A CLEAR CORNEA. THE EVENT RESOLVED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE EVERMOIST LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention AIR OPTIX AQUA SOFT CONTACT LENSES