TECNIS Eyhance IOLs are permanent intraocular implants intended for… — Class II medical device recall Z-0028-2022
Terminated recall by Johnson & Johnson Surgical Vision Inc, reported 2021-10-13, distributed nationwide. Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than bot
| Recall number | Z-0028-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Johnson & Johnson Surgical Vision Inc, Santa Ana, CA, United States |
| Recall initiated | 2021-08-06 |
| Classified | 2021-10-04 |
| Reported by FDA | 2021-10-13 |
| Terminated | 2023-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 1 lens |
| Reason classes | sterility |
| Serial numbers | 5248142104 |
| Model numbers | DIU225U050 |
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 for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.