BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO COMPLETE MOISTURE PLUS

    MDR report key: 2760209 · Received June 15, 2007

    Report

    Report Number
    2760209
    Event Type
    Injury
    Date Received
    June 15, 2007
    Date of Event
    October 9, 2006
    Report Date
    June 12, 2007
    Manufacturer
    AMO
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS INITIALLY SEEN ON (B)(6) 2006, FOR DENSE CORNEAL ULCER ON THE RIGHT EYE - SYMPTOMS OF PAIN, REDNESS, LIGHT SENSITIVE, WATERING, BLURRED VISION STARTING 6 WEEKS PRIOR. PT WAS BEING TREATED FOR POSSIBLE HERPES SIMPLE XVIRUS BY ANOTHER PHYSICIAN, BUT RESULT WAS NOT IMPROVING. ONCE CULTURE CAME BACK THAT WAS DONE ON (B)(6) 2008, CONFIRMING DIAGNOSIS OF ACANTHAMOEBA KERATITIS. PT WAS TREATED FROM (B)(6) 2006 TO (B)(6) 2007. PT WAS LEFT WITH SEVERE CORNEAL SCAR AND REQUIRED A CORNEAL TRANSPLANT IN RIGHT EYE PERFORMED ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO COMPLETE MOISTURE PLUS CONTACT LENS SOLUTION LPN AMO

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Disability USED FROM 11/08/2006 TO 11/22/2006| BACQUACIL| NEOMYCIN EYE DROPS| NEOSPORIN USED FROM 11/22/2006 TO 03/09/2007| BROLENE