BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVE CONTACT LENS

    MDR report key: 9125332 · Received September 26, 2019

    Report

    Report Number
    1627258-2018-00002
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    July 20, 2018
    Report Date
    October 11, 2018
    Manufacturer
    METRO OPTICS OF AUSTIN, INC
    Product Code
    HQD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF LENS DISCOMFORT. DOCTOR (B)(6), REPORTED ABRASIONS FROM LENS WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920686 WAVE CONTACT LENS WAVE ORTHO-K LENS IN BOSTON XO2 HQD METRO OPTICS OF AUSTIN, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR