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Circular Open Loop Posterior Iols & Kratz Elliptic

FDA PMA

Class III (US FDA PMA)

PMA P820072

by Bausch & Lomb, Inc.

Identity

Trade Name
CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC FDA PMA
Generic Name
intraocular lens FDA PMA

Identifiers

PMA Number
P820072 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
PMA Supplement
S011 FDA PMA

The Circular Open Loop Posterior IOLs and Kratz Elliptic are intraocular lenses designed for ophthalmic applications. These devices are used to replace the natural lens of the eye during surgical procedures.

This device is manufactured by Bausch & Lomb, Inc. and is classified as a class 3 medical device. It has received FDA PMA authorization for use in clinical settings.

Frequently asked questions

What is the primary function of the Circular Open Loop Posterior IOLs?

These devices are intraocular lenses intended to serve as a replacement for the natural lens of the eye, which is a standard function for this category of ophthalmic medical device.

Who is the manufacturer of these intraocular lenses?

The Circular Open Loop Posterior IOLs and Kratz Elliptic are manufactured by Bausch & Lomb, Inc., based in Rochester, New York.

Are these lenses FDA authorized?

Yes, these devices have received FDA PMA authorization, which indicates they have undergone the premarket approval process required for class 3 medical devices.

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

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Manufacturer

Manufacturer
Bausch & Lomb, Inc.

Sources (1)

  • FDA PMA P820072 24 fields · synced Sep 18, 2026