BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BRAND COLORED CONTACTS

    MDR report key: 3880275 · Received June 13, 2014

    Report

    Report Number
    MW5036644
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT PURCHASED COLORED CONTACT LENSES OVER THE COUNTER FROM A BEAUTY SUPPLY STORE, WHICH RESULTED IN BILATERAL CORNEAL ULCERS, WHICH MAY LEAD TO PERMANENT VISION DAMAGE. UNK BRAND OF OVER THE COUNTER PURCHASED, NON PRESCRIPTION, COLORED CONTACT LENSES. DATES OF USE: FEW MONTHS. DIAGNOSIS OR REASON FOR USE: CHANGING APPEARANCE OF EYE COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350206 UNKNOWN BRAND COLORED CONTACTS CONTACT LENSES LPL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention