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UV-Absorbing Posterior Chamber Intraocular Lenses

FDA PMA

Class III (US FDA PMA)

PMA P970034

by Aaren Scientific

Identity

Trade Name
MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES FDA PMA
Generic Name
intraocular lens FDA PMA

Identifiers

PMA Number
P970034 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
APWD FDA PMA

The UV-Absorbing Posterior Chamber Intraocular Lenses are designed to permanently replace the natural cataractous crystalline lens and restore useful vision in patients 60 years of age or older who are undergoing extracapsular cataract extraction and primary lens implantation. These lenses are intended for capsular bag placement only and are available in a range of powers from 4 diopters to 34D in 0.5D increments.

These devices are manufactured by Aaren Scientific and are indicated for the visual correction of aphakia. The lenses are supplied in various sizes and are intended for single-use. The device has received FDA PMA authorization, with the product code HQL and regulation number 886.3600.

Frequently asked questions

What is the intended use of these intraocular lenses?

These UV-Absorbing Posterior Chamber Intraocular Lenses are specifically indicated for the visual correction of aphakia in persons 60 years of age or older who are undergoing extracapsular cataract extraction and primary lens implantation. They are designed to permanently replace the natural cataractous crystalline lens and restore useful vision.

In what manner should these lenses be implanted?

These intraocular lenses are intended for capsular bag placement only. They should not be implanted in any other position within the eye as this could affect their performance and potentially lead to complications.

What power ranges are available for these lenses?

The UV-Absorbing Posterior Chamber Intraocular Lenses are available in a range of powers from 4 diopters (D) to 34D in 0.5D increments. This wide range allows for appropriate selection based on individual patient needs and refractive requirements.

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
Aaren Scientific

Sources (1)

  • FDA PMA P970034 24 fields · synced Oct 6, 2026