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Xact Foldable Hydrophobic Acrylic Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens (IOL)

FDA PMA

Class III (US FDA PMA)

PMA P080021

by Bausch & Lomb Incorporated

Identity

Trade Name
XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) FDA PMA
Generic Name
intraocular lens FDA PMA

Identifiers

PMA Number
P080021 FDA PMA
FDA Product Code
HQL 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 Xact Foldable Hydrophobic Acrylic Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens (IOL) is a medical device designed for primary implantation to correct aphakia in adult patients following cataract removal by extracapsular extraction. The lens is intended for placement in the capsular bag and features hydrophobic acrylic material with ultraviolet light-absorbing properties.

This device is supplied in a foldable configuration for implantation during cataract surgery. It is manufactured by Bausch & Lomb Incorporated and has received FDA PMA approval. The device is available in Model X-60 and Model X-70 configurations and is regulated under product code HQL.

Frequently asked questions

What is the Xact Foldable Hydrophobic Acrylic IOL used for?

The Xact Foldable Hydrophobic Acrylic Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens is used for primary implantation to correct aphakia in adult patients who have undergone extracapsular cataract extraction. It is specifically designed to be placed in the capsular bag during cataract surgery.

What are the distinguishing features of the Xact IOL?

The Xact IOL is made of hydrophobic acrylic material with ultraviolet light-absorbing properties. It is designed to be foldable for implantation and is available in two models: X-60 and X-70. These features help protect the eye from harmful UV light while providing visual correction after cataract removal.

What regulatory approvals does the Xact IOL have?

The Xact Foldable Hydrophobic Acrylic Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens has received FDA PMA (Premarket Approval) with the approval number P080021. It is classified as a Class 3 device under product code HQL and is regulated under 886.3600.

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. Sources consulted: Premarket Approval (PMA) - FDA, [PDF] Hydrophobic Acrylic Intraocular Lens - Bausch + Lomb, EnVista hydrophobic acrylic intraocular lens: Glistening free, [PDF] Prospective, Randomized, Controlled Multicenter Study ... - HAL, US9427922B2 - Process for manufacturing an intraocular lens ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Bausch & Lomb Incorporated
FDA Applicant
Bausch & Lomb, Incorporated

Sources (1)

  • FDA PMA P080021 24 fields · synced Oct 6, 2026