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Crystalens Model AT-45 Accommodating Intraocular Lens

FDA PMA

Class III (US FDA PMA)

PMA P030002

by Bausch & Lomb, Inc.

Identity

Trade Name
CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) FDA PMA
Generic Name
Lens, intraocular, accommodative FDA PMA

Identifiers

PMA Number
P030002 FDA PMA
FDA Product Code
NAA 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 Crystalens Model AT-45 is an accommodating intraocular lens designed for primary implantation in the capsular bag of the eye. It is indicated for the visual correction of aphakia in adult patients following cataractous lens removal and provides near, intermediate, and distance vision without spectacles.

The device is supplied sterile and intended for single-use implantation. It is regulated as a Class III medical device under FDA PMA approval (P030002) and is manufactured by Bausch & Lomb, Inc. in Irvine, CA.

Frequently asked questions

What is the Crystalens Model AT-45 used for?

The Crystalens Model AT-45 is indicated for primary implantation in the capsular bag of the eye to correct aphakia in adult patients who have had a cataractous lens removed, providing near, intermediate, and distance vision without spectacles.

Is the Crystalens Model AT-45 a reusable device?

No, the Crystalens Model AT-45 is supplied sterile and intended for single-use implantation only; it is not designed for reuse.

What type of accommodation does the Crystalens Model AT-45 provide?

The Crystalens Model AT-45 provides approximately one diopter of monocular accommodation, enabling a range of vision from near to distance without spectacles.

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 P030002 24 fields · synced Sep 18, 2026