FDA Device recall Z-0028-2022
TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag
- FDA Device
- Class II
- terminated
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag by Johnson And Johnson Surgical Vision, citing 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 recom….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0028-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-06 |
| Published | 2021-10-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Johnson And Johnson Surgical Vision |
| Distribution | US |
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.
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.
Identifiers
| code_info | Model: DIU225U050 UDI Code: (01)05050474745831(17)240414(21)5248142104 Production Order Number: 900001985625 Serial Number: 5248142104 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0028-2022%22
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