TECNIS IOL recallZ-1163-2021 · Johnson & Johnson Surgical Vision Inc · initiated Jan 27, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Johnson & Johnson Surgical Vision Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to the release of nonconforming Intraocular Lenses (IOLs).
FDA root cause category: Process change control
What the company is doing
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]
Recall details
- Recall number
- Z-1163-2021
- Status
- Terminated
- Initiated by the company
- Jan 27, 2021
- Recalling firm
- Johnson & Johnson Surgical Vision Inc
- Quantity
- 27 lenses
- Product code
- MJP
- FDA submissions
- P980040S039
- 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.
Product 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.
Code information (models, lots, serial numbers)
Model Number: ZCT150 UDI/GTIN Codes: (01)05050474552210(17)221123(21)8144121847 5050474552210 Lot Number: 8144121847
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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