FDA Medical Device Recalls (openFDA)
Johnson & Johnson Surgical Vision Inc: 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 number
- Z-1163-2021
- Recalling firm
- Johnson & Johnson Surgical Vision 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.
- Status
- Terminated
- Initiated
- 2021-01-27
- Posted
- not on file
- Terminated
- 2022-11-09
- Reason
- Due to the release of nonconforming Intraocular Lenses (IOLs).
- 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 RegCompliOne@its.jnj.com 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 jturpins@its.jnj.com
- Quantity
- 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.
- Lot, serial or model codes
- Model Number: ZCT150 UDI/GTIN Codes: (01)05050474552210(17)221123(21)8144121847 5050474552210 Lot Number: 8144121847
- 510(k) numbers
- not on file
- PMA numbers
- ["P980040S039"]
- Product code
- MJP
- Firm FEI
- 3003843509
- Firm city
- Santa Ana
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28