Bausch & Lomb recalls enVista Envy IOLs and Toric IOLs starting with EN or ETN models due to reports of toxic anterior segment syndrome (TASS) after implantation. Affected units include specific lot numbers and UDI-DI codes listed in the 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.
Bausch & Lomb is recalling certain enVista Envy IOLs and Toric IOLs that may cause toxic anterior segment syndrome (TASS) after implantation. This condition can lead to eye damage and requires immediate medical attention if symptoms occur.
The recalled IOLs have been linked to reports of toxic anterior segment syndrome (TASS), a rare but serious eye condition that can cause inflammation, pain, and vision damage. TASS occurs when the IOL causes an immune response that affects the front part of the eye.
People who have received or are scheduled to receive the recalled enVista Envy IOLs (models starting with EN) or enVista Envy Toric IOLs (models starting with ETN) from Bausch & Lomb. Patients with these specific models are at risk of developing TASS, a serious eye condition.
Check if your IOL model starts with EN (for enVista Envy IOL) or ETN (for enVista Envy Toric IOL). Look for specific lot numbers and UDI-DI codes listed in the recall details, which include many 3Q and 3R codes and unique serial numbers.
Identify if your IOL model starts with EN or ETN, as these are the affected models.
Reach out to your eye care provider to discuss whether you have the recalled IOL and if you need medical evaluation for TASS symptoms.
Toxic anterior segment syndrome (TASS) is a rare but serious eye condition that can cause inflammation, pain, and vision damage. It occurs when the IOL triggers an immune response in the front part of the eye.
No, but you should contact your eye doctor to determine if you need medical evaluation for TASS symptoms. The recall does not require immediate removal of the IOL but emphasizes monitoring for symptoms.
Check if your IOL model starts with EN (enVista Envy IOL) or ETN (enVista Envy Toric IOL). Affected units have specific lot numbers and UDI-DI codes listed in the recall details.
We’ve drafted a message you can send Bausch & Lomb to request your refund or repair — edit it as you like.
Subject: Recall Z-1680-2025 — Bausch & Lomb Bausch & Lomb Hello, I own a Bausch & Lomb that is covered by recall Z-1680-2025 from Bausch & Lomb. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
