# FDA recall Z-2552-2020

> **Bausch & Lomb Surgical, Inc.** · Class II · device recall initiated 2020-06-09.

## Product

enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.

## Reason for recall

The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.

## Distribution

U.S. Nationwide distribution including in the states of  IN, SC, CT, NV, and NC.

## Key facts

- **Recall number:** Z-2552-2020
- **Recalling firm:** Bausch & Lomb Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-09
- **Report date:** 2020-07-22
- **Termination date:** 2021-02-11

- **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-2552-2020

## Citation

> AI Analytics. FDA recall Z-2552-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2552-2020. Source: US FDA. Licensed CC0.

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