# P240005: enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)

- Pathway: PMA
- Applicant: Bausch & Lomb, Inc.
- Decided: Oct 10, 2024 after 216 days
- Product code: MFK (Lens, Multifocal Intraocular)
- Device class: 3
- Regulation: 21 CFR 886.3600
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Mar 27, 2025 · Class I · Z-1680-2025: 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 i

Source page: https://510kreport.com/device/P240005
Methodology: https://510kreport.com/methodology