BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2289-2023 · Initiated July 6, 2023

    Recall

    Recall Number
    Z-2289-2023
    Event Number
    92666
    Firm
    Johnson & Johnson Surgical Vision, Inc.
    FEI Number
    3012236936
    Product Code
    HQL
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 6, 2023
    Posted
    August 3, 2023
    Address
    31 Technology Dr, Ste 200, Irvine, CA, 92618-2302

    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.

    Action

    On June 07, 20223, Johnson & Johnson Vison issued an "Urgent: Medical Device Recall" notice to affected consignees. Consignees were asked to take the following actions: 1. Identify if any of your inventory contains TECNIS IOLs from the list on pages 5-6 (see page 4 for label examples). 2. Remove all affected TECNIS IOLs from your inventory. No other TECNIS IOLs are affected by this recall. 3. Complete the attached Customer Reply Form (on page 3). We require this information for reconciliation purposes with regulatory agencies, even if you have no inventory. 4. Follow the specific instructions included in the letter "If you have product to be returned" or "If you do not have product to be returned" 5. Share this notice with anyone within your organization that needs to be informed and to any organization where the potentially affected products have been transferred. 6. If you have product complaints or adverse events to report regarding the use of the affected TECNIS IOLs, please inform Johnson & Johnson Vision. If you do report a complaint, please provide the TECNIS IOL serial number and, if a patient was involved, the date of surgery, a description of the event and patient outcome. 7. In addition, you may report any adverse events experienced or quality issues with the use of the TECNIS IOLs to the FDA's MedWatch Adverse Event Reporting program by phone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch/report.htm.

    Distribution

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

    Quantity

    61 units