BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO COMPLETE MOISTURE PLUS

    MDR report key: 967839 · Received December 17, 2007

    Report

    Report Number
    MW5004719
    Event Type
    Injury
    Date Received
    December 17, 2007
    Date of Event
    December 16, 2007
    Report Date
    December 17, 2007
    Manufacturer
    AMO
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT "AMO COMPLETE MOISTURE PLUS" FOR STANDARD CONTACT SOLUTION. ON OUR WAY TO A CHRISTMAS PROGRAM APPROX 1 HR AWAY, SHE WAS FEELING SEVERE EYE DISCOMFORT. SHE HAD BEEN SOLD THE CONTACTS AND SOLUTION BACK. I HAD TO TAKE HER TO THE ER YESTERDAY. SHE WAS EXPERIENCING EXTREMELY SEVERE SWELLING OF HER EYE LIDS, CLOUDED VISION, EYES SEVERELY WATERING, AND EXTREME PAIN. THEY TREATED HER FOR INFECTON AND REFFERED HER TO A OPHTHALMOLOGIST TODAY. HIS FINDINGS WERE THAT THE DAMAGE RESEMBLED A CHEMICAL BURN AND CORNEAL DAMAGE. HE HAS ASKED US TO RETURN TOMORROW FOR FURTHER EVALUATION. SHE HAS NO EXPOSURE TO ANY CHEMICALS OR OTHER FOREIGN SUBSTANCES. THE DOCTOR DID NOT TELL US THE PRODUCT HAD BEEN RECALLED IN MAY OF 2007. DATES OF USE 2007. DIAGNOSIS OR REASON FOR USE: CONTACT CLEANING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO COMPLETE MOISTURE PLUS NONE LPN AMO AB03244

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O PER CLEANING