PMA
P240005: enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)
FDA PMA · Lens, multifocal intraocular · Bausch & Lomb, Inc.
Key facts
| PMA number | P240005 |
|---|---|
| Trade name | enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) |
| Generic name | Lens, multifocal intraocular |
| Applicant | Bausch & Lomb, Inc. |
| Owner/operator | Bausch & Lomb Incorporated |
| Product code | MFK |
| Approval date | Oct 10, 2024 |
| Establishment registration | 1119279 |
| FEI number | 1119279 |
At a glance
- 1–9 Supplements
- Sep 30, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1,000+ UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: