- Device
- enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P240005
- Supplement
- S003
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2025-07-30
- Decision code
- APPR
- Date received
- 2025-02-14
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a replacement of the optical metrology platform for dioptric power and image quality inspection of enVista Envy™ and enVista Envy™ Toric Hydrophobic Acrylic Intraocular Lenses