The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1680-2025·Announced 2025-05-14

Intraocular Lenses enVista Envy and Envy Toric Recalled

Bausch & Lomb is recalling enVista Envy and enVista Envy Toric intraocular lenses due to increased reports of toxic anterior segment syndrome (TASS) following implantation.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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. Although the source states an "increased number of reports" of TASS without specifying illness count or hospitalization details, Class I recalls are defined as situations where there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls score at least 4.

Plain-English summary

Bausch & Lomb Surgical, Inc. is recalling enVista Envy IOL (all models starting with EN) and enVista Envy Toric IOL (all models starting with ETN) intraocular lenses in response to an increased number of reports of toxic anterior segment syndrome (TASS) occurring in conjunction with implantation of these devices.

TASS is an inflammatory reaction that can occur following cataract surgery and intraocular lens implantation. The recall affects 48,237 units distributed worldwide, including throughout the United States, Puerto Rico, Guam, Canada, Australia, and multiple European and international locations.

Patients who have received one of the recalled intraocular lenses should consult their eye care provider if they experience symptoms following lens implantation. Healthcare providers should review the FDA recall notice for detailed lot and UDI information to identify affected devices.

The recalled product

Product
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Manufacturer
Bausch & Lomb Surgical, Inc.
Category
Medical Device — Ophthalmic / Intraocular Lens
Hazard
Affected units
48,237

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 Envy IOL (ENU)/3Q24764
  • 3Q24935
  • 3Q25113
  • 3Q25833
  • 3Q26256
  • 3Q26257
  • 3Q26538
  • 3Q26601
  • 3Q26603
  • 3Q26604
  • 3Q26679
  • 3Q26680
  • 3Q27353
  • 3Q27447
  • 3Q27457
  • 3Q27905
  • 3Q27907
  • 3Q28001
  • 3Q28002
  • 3Q28124

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 →

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