BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUAL HEALTHWEAR INSTANT SUNGLASSES

    MDR report key: 184346 · Received August 26, 1998

    Report

    Report Number
    2513853-1998-00001
    Event Type
    Injury
    Date Received
    August 26, 1998
    Date of Event
    September 15, 1995
    Report Date
    August 3, 1998
    Manufacturer
    YORKTOWNE OPTICAL CO., INC. MIDLANTIC ACCESSORIES CO.
    Product Code
    HQY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER SUFFERED CORNEAL ABRASION AFTER INSERTING ONTO EYEGLASSES. THE REPORTED INCIDENT OCCURRED IN ARUBA, BUT THE SUNGLASSES WERE PURCHASED IN MANCHESTER, CONNECTICUT AT A STORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISUAL HEALTHWEAR INSTANT SUNGLASSES SUNGLASSES HQY YORKTOWNE OPTICAL CO., INC. MIDLANTIC ACCESSORIES CO. REGULAR NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention