BEUDAMED
    FDA Enforcement Class II Ongoing

    TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only

    Recall: Z-2288-2023 · Reported August 9, 2023

    Enforcement

    Recall Number
    Z-2288-2023
    Event ID
    92666
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Johnson & Johnson Surgical Vision, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 9, 2023
    Initiation Date
    July 6, 2023
    Classification Date
    August 3, 2023
    Address
    31 Technology Dr Ste 200, N/A, Irvine, CA, 92618-2302, United States

    Description

    TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only

    Reason

    Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

    Code Info

    UDI-DI: 5050474579163/ Serial Numbers: 8210142244, 8210152244, 8210162244, 8210172244, 8210182244, 8210192244, 8210202244, 8210212244, 8210222244, 8210232244, 8210242244, 8210252244, 8210262244, 8210272244, 8210282244, 8210292244, 8210302244, 8210312244, 8210322244, 8210332244, 8210342244, 8210352244, 8210362244, 8210372244, 8210382244, 8210392244, 8210402244, 8210412244, 8210422244, 8210432244, 8210442244, 8210452244, 8210462244, 8210472244, 8210482244, 8210492244, 8210502244, 8210512244, 8210522244, 8210532244, 8210542244, 8210552244,

    Distribution

    International distribution to the countries of China, India, Korea.

    Quantity

    42