BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTACLE FRAMES WITH PRESCRIPTION SPECTACLE LENSES

    MDR report key: 16278296 · Received January 31, 2023

    Report

    Report Number
    MW5114605
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    January 27, 2023
    Report Date
    January 28, 2023
    Manufacturer
    WARBY PARKER
    Product Code
    HQZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED A PAIR OF GLASSES FROM (B)(6), AND THE FRAMES ARE DEFECTIVE. THE ACETATE IS WARPED AROUND THE LENS FOR THE RIGHT EYE, CAUSING THE LENS TO SIT AT THE WRONG VERTICAL ANGLE, WHICH IS HAVING A NEGATIVE IMPACT ON MY SIGHT WHEN WEARING THE GLASSES. I HAVE REPORTED TO THE COMPANY (EMAIL SENT 1/27/2023) AND AM TRYING TO GET THE GLASSES REMADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902180 SPECTACLE FRAMES WITH PRESCRIPTION SPECTACLE LENSES FRAME, SPECTACLE HQZ WARBY PARKER M 332

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male