# FDA recall Z-1679-2025

> **Bausch & Lomb Surgical, Inc.** · Class I · device recall initiated 2025-03-27.

## Product

Intraocular lens. enVista Monofocal IOL, All models starting with EE;  enVista Aspire IOL, All models starting with EA;  enVista Monofocal Toric IOL, All models starting with ETE;  enVista Aspire Toric IOL, All models starting with ETA;

## Reason for recall

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

## Distribution

Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.

## Key facts

- **Recall number:** Z-1679-2025
- **Recalling firm:** Bausch & Lomb Surgical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-27
- **Report date:** 2025-05-14

- **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-1679-2025

## Citation

> AI Analytics. FDA recall Z-1679-2025. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1679-2025. Source: US FDA. Licensed CC0.

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