Z-1163-2021Class II

TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL -

Name: Z-1163-2021 TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL -
Creator: Johnson & Johnson Surgical Vision Inc
Published: 2021-01-27
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2021-01-27 / Terminated

FDA source

Johnson & Johnson Surgical Vision Inc began a recall of TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag on 2021-01-27. FDA classified it as Class II and gives the reason as "Due to the release of nonconforming Intraocular Lenses (IOLs)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1163-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-27
Posted: 2021-03-03
Terminated: 2022-11-09
Recalling firm: Advanced Medical Optics, Inc.
Product: TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
Product code: MJP Lens, Intraocular, Toric Optics
Reason for recall: Due to the release of nonconforming Intraocular Lenses (IOLs).
FDA root cause: Process change control
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]
Quantity in commerce: 27 lenses
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 codes and lots: Model Number: ZCT150 UDI/GTIN Codes: (01)05050474552210(17)221123(21)8144121847 5050474552210 Lot Number: 8144121847

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1163-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1163-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-10	2021-03-03

Product code MJP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)