BEUDAMED
    FDA Enforcement Class II Ongoing

    TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

    Recall: Z-2289-2023 · Reported August 9, 2023

    Enforcement

    Recall Number
    Z-2289-2023
    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 Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

    Reason

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

    Code Info

    UDI-DI: N/A/ Serial Numbers: 8046642236, 8046652236, 8046662236, 8046672236, 8046682236, 8046692236, 8046702236, 8046712236, 8046722236, 8046732236, 8046742236, 8046752236, 8046762236, 8046772236, 8046782236, 8046792236, 8046802236, 8046812236, 8046822236, 8046832236, 8046842236, 8046852236, 8046862236, 8046872236, 8046882236, 8046892236, 8046902236, 8046912236, 8046922236, 8046932236, 8046942236, 8046952236, 8046962236, 8046972236, 8046982236, 8046992236, 8047002236, 8047012236, 8047022236, 8047032236, 8047042236, 8047052236, 8047062236, 8047072236, 8047082236, 8047102236, 8047112236, 8047122236, 8047132236, 8047142236, 8047152236, 8047162236, 8047172236, 8047182236, 8047192236, 8047202236, 8047212236, 8047222236, 8047232236, 8047242236, 8047252236

    Distribution

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

    Quantity

    61 units