BEUDAMED
    FDA Recall Terminated

    TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.

    Recall: Z-1163-2021 · Initiated January 27, 2021

    Recall

    Recall Number
    Z-1163-2021
    Event Number
    87320
    Firm
    Johnson & Johnson Surgical Vision Inc
    FEI Number
    3003843509
    Product Code
    MJP
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    January 27, 2021
    Terminated
    November 9, 2022
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933

    Description

    TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.

    Reason

    Due to the release of nonconforming Intraocular Lenses (IOLs).

    Action

    On 01/27/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via confirmed mail to customers informing them that due to investigation results, following a customer complaint, which confirmed a hyperopic patient outcome post implantation for an Intraocular Lens (IOL). The investigation for this complaint determined that this occurred due to inadvertent release of nonconforming product (Product labeled as 23.5D but measured to be 17.5D). Customers are instructed to: 1) Compare their inventory against the attached list on page 3. The IOL serial number is displayed on the end of each individual unit carton (see page 3 for label example). 2) Discontinue using and remove from their inventory all affected IOLs. 3) Complete and return the attached Customer Reply Form to acknowledge receipt of this Recall Notice, even if they have no inventory. The Recalling Firm requires this information for reconciliation purposes with regulatory agencies. The Recalling Firm has pre-filled the Customer Reply Form with the IOL serial number(s) that was(were) shipped to them and marked accordingly where product has already been returned. The completed Customer Reply Form should be emailed to [email protected] or faxed to 1-714-460-0466 within 3 business days of receipt of the recall notification letter. 4) Should customers have product to return with the serial number listed on page 3, they are asked to contact Customer Support at 1-877-266-4543 to arrange pick up of affected product. 5) The Recall Notification Letter should be shared with anyone who needs to be aware within the customer's organization or to any organization where the potentially affected products have been transferred. Any questions contact the Public Contact/Director, Quality Assurance at 949-480-7526 or email [email protected]

    Distribution

    U.S. Nationwide distribution in the states of AL, AZ, CA, FL, GA, IL, LA, MI, MN, NC, NY, OH, PA, SC, TN, TX, UT and WA.

    Quantity

    27 lenses