BEUDAMED
    FDA Enforcement Class II Terminated

    TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.

    Recall: Z-0028-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0028-2022
    Event ID
    88564
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Johnson & Johnson Surgical Vision Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 13, 2021
    Initiation Date
    August 6, 2021
    Classification Date
    October 4, 2021
    Termination Date
    March 6, 2023
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933, United States

    Description

    TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.

    Reason

    Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.

    Code Info

    Model: DIU225U050 UDI Code: (01)05050474745831(17)240414(21)5248142104 Production Order Number: 900001985625 Serial Number: 5248142104

    Distribution

    U.S. Nationwide distribution in the state of IL.

    Quantity

    1 lens