# FDA recall Z-0028-2022

> **Johnson & Johnson Surgical Vision Inc** · Class II · device recall initiated 2021-08-06.

## 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.

## Distribution

U.S. Nationwide distribution in the state of IL.

## Key facts

- **Recall number:** Z-0028-2022
- **Recalling firm:** Johnson & Johnson Surgical Vision Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-06
- **Report date:** 2021-10-13
- **Termination date:** 2023-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Ana, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0028-2022

## Citation

> AI Analytics. FDA recall Z-0028-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0028-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*