- Device
- enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P240005
- Supplement
- S002
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2024-12-11
- Decision code
- OK30
- Date received
- 2024-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to remove the ‘deflash polish operations’ utilized in the current enVista Envy IOL manufacturing process