PMA P240005S001

Device: enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P240005
Supplement: S001
Product code: MFK
Decision date: 2025-01-14
Classification: Ophthalmic
Generic name: Lens, multifocal intraocular
Approval order statement: approval for co-packaging of the enVista IOLs with the EyeGility Inserter (model numbers EC20E, EC20A, EC20N, EC24E, EC24A, EC24N, ETC20E, ETC20A, ETC20N, ETC24E, ETC24A, ETC24N)

Current openFDA PMA Record#

Device: enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P240005
Supplement: S001
Product code: MFK
Generic name: Lens, multifocal intraocular
Decision date: 2025-01-14
Decision code: APPR
Date received: 2024-10-25
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for co-packaging of the enVista IOLs with the EyeGility Inserter (model numbers EC20E, EC20A, EC20N, EC24E, EC24A, EC24N, ETC20E, ETC20A, ETC20N, ETC24E, ETC24A, ETC24N)