BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SIMPLICITY

    MDR report key: 425301 · Received October 28, 2002

    Report

    Report Number
    MW1026574
    Event Type
    Injury
    Date Received
    October 28, 2002
    Date of Event
    October 23, 2002
    Report Date
    October 28, 2002
    Manufacturer
    POLYMER TECHNOLOGY USA
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    USE OF SOLUTION SOFTENED RIGID GAS PERMEABLE CONTACT LENSES AND CAUSED STINGING AND BLURRED VISION WHEN LENSES WERE SOAKED IN SOLUTION AND THEN INSERTED INTO EYES. REQUIRED REMOVAL OF LENSES AND RINSING OF EYES TO ALLEVIATE STINGING. THE SOLUTION HAS A PERFUMED SOAP ODOR. PRINTED ON THE BOTTLE WERE THE FOLLOWING EXPIRATION DATE AND LOT NUMBER: 2004-04 AND GB2092. PRINTED ON THE CARTON WERE THE FOLLOWING EXPIRATION DATE AND LOT NUMBER: 2004-02 AND GB2076.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SIMPLICITY * LPN POLYMER TECHNOLOGY USA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention