PMA P240005S008
- Device
- enVista Envy™ Hydrophobic Acrylic Intraocular Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P240005
- Supplement
- S008
- Product code
- MFK
- Decision date
- 2026-09-30
- Classification
- Ophthalmic
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- adding a new ISO Class 7 manufacturing cleanroom at the Clearwater Florida facility
Current openFDA PMA Record#
- Device
- enVista Envy™ Hydrophobic Acrylic Intraocular Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P240005
- Supplement
- S008
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2026-09-30
- Decision code
- OK30
- Date received
- 2026-09-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adding a new ISO Class 7 manufacturing cleanroom at the Clearwater Florida facility