PMA P240005

Device
enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)
Applicant
Bausch & Lomb, Inc.
PMA number
P240005
Supplement
S005
Product code
MFK
Decision date
2026-08-12
Classification
Ophthalmic
Generic name
Lens, multifocal intraocular
Approval order statement
an update to the A Constant for enVista Envy™ hydrophobic acrylic intraocular lens (IOL) and enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)

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
S005
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2026-08-12
Decision code
APPR
Date received
2026-07-14
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
an update to the A Constant for enVista Envy™ hydrophobic acrylic intraocular lens (IOL) and enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)