BEUDAMED
    FDA Recall Open, Classified

    TECNIS Toric II OptiBlue IOL Models ZCW

    Recall: Z-0735-2024 · Initiated December 12, 2023

    Recall

    Recall Number
    Z-0735-2024
    Event Number
    93523
    Firm
    Johnson & Johnson Surgical Vision, Inc.
    FEI Number
    3012236936
    Product Code
    MJP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 12, 2023
    Posted
    January 16, 2024
    Address
    31 Technology Dr, Ste 200, Irvine, CA, 92618-2302

    Description

    TECNIS Toric II OptiBlue IOL Models ZCW

    Reason

    Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.

    Action

    On or about 12/12/2023, the firm send an "URGENT: MEDICAL DEVICE RECALL" Letter via hand-delivery to customer/distributors informing that Johnson & Johnson Vision is initiating an Action due to the identification of a limited quantity of TECNIS Toric II OptiBlue IOLs in which the cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks. Customer are instructed to: 1.Identify if any of their inventory contains TECNIS Toric II OptiBlue IOLs from the list on page 5. 2.Remove all affected IOLs from their inventory. 3.Complete the attached Customer Reply Form. The firm requires this information for reconciliation purposes with regulatory agencies, even if you have no inventory. If customers have product to be returned: Complete the Customer Reply Form, noting the serial number of the TECNIS Toric II OptiBlue IOLs. "Contact Customer Support to obtain an RGA number and arrange product return. "Email Customer Reply Form within 3 business days of receipt of this letter. "Return affected product as soon as possible. A credit will be issued upon receipt of the customer reply form and product. If customer does not have product to be returned: " Review patient records to confirm implantation of the impacted lens. " If no unexpected postoperative outcome occurred following the implantation of the TECNIS Toric II OptiBlue, no further action is required after Customer Reply Form has been returned. " If issues were encountered, please inform JJSV. If customer is reporting a complaint, provide the serial number, the date of surgery, a description of the event, and patient outcome. " Complete and return the Customer Reply Form and email within 3 business days of receipt of this letter.

    Distribution

    International distribution to the country of Japan.

    Quantity

    36