BEUDAMED
    FDA Recall 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 · Initiated August 6, 2021

    Recall

    Recall Number
    Z-0028-2022
    Event Number
    88564
    Firm
    Johnson & Johnson Surgical Vision Inc
    FEI Number
    3003843509
    Product Code
    MJP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 6, 2021
    Terminated
    March 6, 2023
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933

    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.

    Action

    On 08/18/2021, the firm sent via FedEx standard overnight an "URGENT DEVICE Recall" Letter informing customers that it inadvertently release of nonconforming product (high endotoxin levels). Customers are instructed to: 1. Complete and return the Customer Reply Form to acknowledge receipt of the Recall Notice and email to [email protected] within 3 business days of receipt of the recall notice. 2. Review their patient records to confirm implantation of the impacted lens. 3. If no unexpected postoperative outcome occurred following implantation, no further action is required after Customer Reply Form has been returned. 4. If issues were encountered, inform the Recall Firm by calling 877-266-4543, Option 2. If reporting a complaint, provide the serial number, the date of surgery, a description of the event, and patient outcome. For any questions, contact Customer Support at; 877-266-4543, Option 2 or email [email protected]

    Distribution

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

    Quantity

    1 lens