Recall archive / FDA company announcement
enVista Aspire: enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses — FDA announcement Apr 7, 2025
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Apr 7, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses
- Reason
- Increased frequency of reports of toxic anterior segment syndrome
- Classification
- Not supplied
- Recalling firm
- Bausch + Lomb Corporation
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 50abed3500f9b3d5
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Description | Model Identifier: | Lots | UDI-DI; enVista Monofocal IOL | All models starting with EE | ALL | Click here for UDI list; enVista Aspire IOL | All models starting with EA | | ; enVista Envy IOL | All models starting with EN | | ; enVista Monofocal Toric IOL | All models starting with ETE | | ; enVista Aspire Toric IOL | All models starting with ETA | | ; enVista Envy Toric IOL | All models starting with ETN | | |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| Model Description | Model Identifier: | Lots | UDI-DI |
| enVista Monofocal IOL | All models starting with EE | ALL | Click here for UDI list |
| enVista Aspire IOL | All models starting with EA | ||
| enVista Envy IOL | All models starting with EN | ||
| enVista Monofocal Toric IOL | All models starting with ETE | ||
| enVista Aspire Toric IOL | All models starting with ETA | ||
| enVista Envy Toric IOL | All models starting with ETN |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Apr 7, 2025
- Company announcement date
- Apr 3, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.