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enVista Envy Hydrophobic Acrylic Intraocular Lens IOL

FDA PMA

Class III (US FDA PMA)

PMA P240005

by Bausch & Lomb, Inc.

Identity

Trade Name
enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) FDA PMA
Generic Name
Lens, multifocal intraocular FDA PMA

Identifiers

PMA Number
P240005 FDA PMA
FDA Product Code
MFK FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 886.3600 FDA PMA
Regulation Number
886.3600 FDA PMA
Advisory Committee
Ophthalmic FDA PMA
FDA Decision
APPR Approved FDA PMA

The enVista Envy hydrophobic acrylic intraocular lens (IOL) is a multifocal lens indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia with less than or equal to 1.0 D preoperative corneal astigmatism following removal of a cataractous lens. It is designed to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity while maintaining comparable distance visual acuity to an aspheric monofocal IOL.

Supplied in non-preloaded (model EN) and preloaded into shuttle (model EPN) configurations, the lens is intended for single-use surgical implantation. It is a Class III device authorized under FDA PMA P240005 and manufactured by Bausch & Lomb, Inc. in Rochester, NY.

Frequently asked questions

What models are available for the enVista Envy hydrophobic acrylic IOL?

The enVista Envy hydrophobic acrylic IOL is available in two models: the non-preloaded model EN and the preloaded into shuttle model EPN, as specified in the device data.

What is the maximum preoperative corneal astigmatism allowed for implantation of the enVista Envy IOL?

The enVista Envy hydrophobic acrylic IOL is indicated for use in adult patients with less than or equal to 1.0 D preoperative corneal astigmatism following cataract removal.

Is the enVista Envy IOL a multifocal lens?

Yes, the enVista Envy hydrophobic acrylic IOL is classified as a multifocal intraocular lens, as indicated by its generic name and approval description for improving intermediate and near visual acuity while maintaining distance vision.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Bausch & Lomb, Inc.

Sources (1)

  • FDA PMA P240005 23 fields · synced Oct 6, 2026