# FDA recall Z-0519-2021

> **Bausch & Lomb Surgical, Inc.** · Class II · device recall initiated 2020-11-07.

## Product

MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.

## Reason for recall

Product may be missing toric axis marks.

## Distribution

US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH.

## Key facts

- **Recall number:** Z-0519-2021
- **Recalling firm:** Bausch & Lomb Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-07
- **Report date:** 2020-12-09
- **Termination date:** 2024-07-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Clearwater, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0519-2021

## Citation

> AI Analytics. FDA recall Z-0519-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0519-2021. Source: US FDA. Licensed CC0.

---

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