BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE COMFORT PLUS MULTI-PURPOSE SOLUTION

    MDR report key: 303021 · Received October 31, 2000

    Report

    Report Number
    2011068-2000-00018
    Event Type
    Injury
    Date Received
    October 31, 2000
    Date of Event
    February 5, 2000
    Report Date
    July 10, 2000
    Manufacturer
    ALLERGAN .
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A DR REPORTED THAT A PT EXPERIENCED AN OCULAR BURNING SENSATION, OCULAR STINGING AND CORNEAL INFILTRATES AFTER USING COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION. IN FOLLOW-UP, THE DR REPORTED THAT THE PT INITIALLY STARTED USING THE PRODUCT IN 1999, AND 2000, PRESENTED WITH BURNING AND STINGING AND WAS DIAGNOSED WITH INFILTRATES AND SLIGHT PUNCTATE KERATITIS IN BOTH EYES. THE DR THEN TREATED THE PT WITH FML, AND IMPROVEMENT IN THE PT'S CONDITION WAS NOTED TWO DAYS FOLLOWING THE TREATMENT. CONTACT LENS WEAR WITH NEW LENSES WAS STARTED ONE WEEK LATER. ONE MONTH AFTER WEARING PT'S CONTACT LENSES AGAIN, THE INFILTRATES WERE LARGER THAN IN THE PAST. CONTACT LENS WEAR WAS STOPPED AGAIN AND THE PT WAS TREATED AGAIN WITH FML. ONE MONTH AFTER WEARING LENSES AGAIN, THE INFILTRATES HAD RETURNED AGAIN. THE FML REGIMEN WAS STARTED A THIRD TIME AND WHEN THE PT RETURNED TO LENS WEAR, PT WAS SWITCHED TO ULTRACARE. AFTER ONE-MONTH USING ULTRACARE, THE PT HAD NO INFILTRATES, JUST SCARS FROM THE PREVIOUS INFILTRATES. CORRECTIVE TREATMENT: FML, ULTRACARE, NEW CONTACT LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE COMFORT PLUS MULTI-PURPOSE SOLUTION CONTACT LENS CARE PRODUCT LPN ALLERGAN . NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention CONTACT LENS.