enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses
Product details
- enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses
Company announcement
Bausch + Lomb has voluntarily recalled enVista Aspire, enVista Envy, and certain enVista Monofocal Intraocular Lenses in the United States due to an increased number of reports of Toxic Anterior Segment Syndrome (TASS).
All enVista TASS cases reported to Bausch + Lomb to date responded quickly to treatment, and none have required removal of the lens.
The recall includes all lots of 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.
The company is communicating with eye care professionals, providing instructions for product return. Patients experiencing eye discomfort should contact their eyecare professional immediately. Eyecare professionals should monitor cataract surgery patients closely for at least 48 hours after surgery and instruct patients with new or worsening symptoms to contact their office immediately.
Date of recall announcement: April 3, 2025.
Risk:
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.
Impacted states: Nationwide
Products:
- enVista Monofocal IOL
- enVista Aspire IOL
- enVista Envy IOL
- enVista Monofocal Toric IOL
- enVista Aspire Toric IOL
- enVista Envy Toric IOL
Contact
For more information, call (800) 338-2020.