Severe FDA (Devices)·Z-1679-2025·Announced 2025-05-14

Intraocular Lens Recalled Due to Toxic Anterior Segment Syndrome Reports

Bausch & Lomb has recalled multiple enVista intraocular lens models used in cataract surgery due to reports of toxic anterior segment syndrome (TASS) in the United States. TASS is an inflammatory reaction in the front of the eye following lens implantation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall, which per the rubric requires a severity score of at least 4. Although the source text does not report specific hospitalizations or illnesses, the Class I designation itself—indicating a serious health hazard—mandates a Severe (score 4) classification.

Plain-English summary

Bausch & Lomb Surgical, Inc. is recalling enVista intraocular lenses (IOLs) following an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of certain enVista models in the United States. The affected products include enVista Monofocal IOL (models starting with EE), enVista Aspire IOL (models starting with EA), enVista Monofocal Toric IOL (models starting with ETE), and enVista Aspire Toric IOL (models starting with ETA).

TASS is an anterior eye inflammation that can occur following intraocular lens implantation. The agency classified this as a Class I recall, indicating a serious health hazard.

Approximately 236,840 units have been distributed worldwide, including nationwide distribution in the United States, Puerto Rico, Guam, and multiple countries across North America, Europe, and other regions. Patients who have had these lenses implanted and experience eye symptoms should contact their eye care provider immediately.

The recalled product

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;
Manufacturer: Bausch & Lomb Surgical, Inc.
Category: Medical Device — Ophthalmic / Intraocular Lens
Hazard: toxic-anterior-segment-syndrome
inflammation
Affected units: 236,840

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Description/Lots/UDI-DI: enVista Monofocal IOL (EEU)/3Q25120
3Q25326
3Q25327
3Q25347
3Q25348
3Q25425
3Q25426
3Q25427
3Q25507
3Q25508
3Q25509
3Q25510
3Q25511
3Q25548
3Q25549
3Q25550
3Q25628
3Q25632
3Q25730
3Q25731

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Bausch & Lomb Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Bausch & Lomb Surgical, Inc.

See all →

High
Intraocular lenses recalled after off-power error produced wrong diopter strength
FDA (Devices) · 2025-09-03
Severe
Intraocular Lenses enVista Envy and Envy Toric Recalled
FDA (Devices) · 2025-05-14
Moderate
Bausch & Lomb Recalls Toric Intraocular Lenses Due to Missing Axis Marks
FDA (Devices) · 2020-12-09
High
Bausch & Lomb Recalls enVista Toric Intraocular Lenses Due to Axis Misalignment
FDA (Devices) · 2020-07-22
Moderate
Bausch & Lomb Recalls enVista Intraocular Lenses Due to Surface Imperfections
FDA (Devices) · 2018-12-26

Same hazard · toxic anterior segment syndrome