Elevated risk U.S. Food and Drug Administration

enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal recall: Increased frequency of reports of toxic anterior segment syndrome

Recall published 1+ years ago

Increased frequency of reports of toxic anterior segment syndrome

The hazard: Harmful chemical exposure

This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

What the notice says: TASS, a potential complication in any cataract surgery, is an inflammatory reaction inside the eye that can have a variety of causes.

Why it matters: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.

Symptoms and when to call a doctor

For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
April 3, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
enVista Aspire
Product type
Medical devices

Products covered by this recall

enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses

What the company announced

Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced a voluntary recall of intraocular lenses (IOLs) on its enVista platform. This action was taken after the company received reports of complications, the cause of which could not immediately be explained.

“As much as we believe in the enVista platform, patient safety will always be our number one priority,” said Brent Saunders, chairman and CEO, Bausch + Lomb. “Surgeons and patients trust Bausch + Lomb, and I believe that this voluntary recall is the best thing we can do to honor that trust.”

The recall is in response to an increased number of reports of toxic anterior segment syndrome (TASS), and includes all lots of the following enVista Aspire, enVista Aspire Toric, enVista Envy and enVista Envy Toric, as well as enVista monofocal and enVista monofocal Toric IOL models in the U.S.

Impacted Product

  • Model Description: enVista Monofocal IOL · Model Identifier:: All models starting with EE · Lots: ALL · UDI-DI: Click here for UDI list
  • Model Description: enVista Aspire IOL · Model Identifier:: All models starting with EA
  • Model Description: enVista Envy IOL · Model Identifier:: All models starting with EN
  • Model Description: enVista Monofocal Toric IOL · Model Identifier:: All models starting with ETE
  • Model Description: enVista Aspire Toric IOL · Model Identifier:: All models starting with ETA
  • Model Description: enVista Envy Toric IOL · Model Identifier:: All models starting with ETN

TASS, a potential complication in any cataract surgery, is an inflammatory reaction inside the eye that can have a variety of causes. When it occurs, this complication typically appears 12 – 48 hours after eye surgery. All enVista TASS cases reported to Bausch + Lomb to date responded quickly to treatment, and none have required removal of the lens.

“These reports represent only 1-2% of implanted lenses, with a positive prognosis for everyone involved,” Saunders continued. “We look forward to identifying a root cause and bringing the enVista platform back to market.”

Communications to eye care professionals are underway, with instructions for product return. Click here for a message from Saunders to customers, here for a copy of the U.S. version of the recall notice and here for a TASS fact sheet.

For Patients : Cataract surgery patients experiencing eye discomfort should contact their eyecare professional immediately.

For Eyecare Professionals : Please continue to closely monitor cataract surgery patients for at least 48 hours after surgery. Please instruct patients with new or worsening symptoms to contact your office immediately.

To report an adverse event, please contact Bausch + Lomb Customer Service at 1-800-338-2020, option 1, or submit a report to U.S. FDA’s MedWatch program (call 1-800-332-1088 to request a form). For more information about this recall, please contact Bausch + Lomb Customer Service at 1-800-338-2020, option 9, 8:00 am to 4:30 pm Eastern, Monday through Friday.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

What to do about Chemical

enVista Aspire — This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

  1. Stop using the product and keep it away from children and pets.
  2. If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.
  3. Do not pour it down a drain or into a bin without checking local hazardous-waste rules, and never mix it with another cleaner.
  4. Ventilate the room if the product was sprayed or applied there.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.

Company contact: Bausch + Lomb Corporation — Consumers: Bausch + Lomb Customer Service, (800) 338-2020 — Media: Caryn Marshall, (908) 493-1381, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was enVista Aspire medical devices recalled?

Increased frequency of reports of toxic anterior segment syndrome TASS, a potential complication in any cataract surgery, is an inflammatory reaction inside the eye that can have a variety of causes.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Stop using the product and keep it away from children and pets.

Can I get my money back?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

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