- Device
- enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P240005
- Supplement
- S004
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2025-05-30
- Decision code
- OK30
- Date received
- 2025-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updates to the work instruction and specification used for the procurement of styrene for the manufacturing of enVista IOLs