FDA Medical Device Recalls (openFDA)
Johnson & Johnson Surgical Vision Inc: TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.
- Recall number
- Z-0028-2022
- Recalling firm
- Johnson & Johnson Surgical Vision Inc
- Product
- TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.
- Status
- Terminated
- Initiated
- 2021-08-06
- Posted
- not on file
- Terminated
- 2023-03-06
- Reason
- Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.
- Root cause
- Process control
- Action
- On 08/18/2021, the firm sent via FedEx standard overnight an "URGENT DEVICE Recall" Letter informing customers that it inadvertently release of nonconforming product (high endotoxin levels). Customers are instructed to: 1. Complete and return the Customer Reply Form to acknowledge receipt of the Recall Notice and email to RegCompliOne@its.jnj.com within 3 business days of receipt of the recall notice. 2. Review their patient records to confirm implantation of the impacted lens. 3. If no unexpected postoperative outcome occurred following implantation, no further action is required after Customer Reply Form has been returned. 4. If issues were encountered, inform the Recall Firm by calling 877-266-4543, Option 2. If reporting a complaint, provide the serial number, the date of surgery, a description of the event, and patient outcome. For any questions, contact Customer Support at; 877-266-4543, Option 2 or email RegCompliOne@its.jnj.com
- Quantity
- 1 lens
- Distribution
- U.S. Nationwide distribution in the state of IL.
- Lot, serial or model codes
- Model: DIU225U050 UDI Code: (01)05050474745831(17)240414(21)5248142104 Production Order Number: 900001985625 Serial Number: 5248142104
- 510(k) numbers
- not on file
- PMA numbers
- ["P980040S117"]
- 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