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Elastimide IOL Model AQ-2010

FDA PMA

Class III (US FDA PMA)

PMA P910060

by Staar Surgical Co.

Identity

Trade Name
ELASTIMIDE(TM) IOL MODEL AQ-2010 FDA PMA
Generic Name
intraocular lens FDA PMA

Identifiers

PMA Number
P910060 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
S001 (Normal 180 Day Track) FDA PMA

The Elastimide IOL Model AQ-2010 is an intraocular lens designed for implantation in the eye to replace the natural lens. It is classified as a Class III medical device and is intended for use in ophthalmic surgical procedures.

This device is supplied sterile and is intended for single-use implantation. It is manufactured by Staar Surgical Co. in Monrovia, California, and received FDA PMA approval on April 20, 1994, under regulation number 886.3600 and product code HQL.

Frequently asked questions

What is the Elastimide IOL Model AQ-2010 used for?

The Elastimide IOL Model AQ-2010 is an intraocular lens used to replace the natural crystalline lens during cataract surgery or refractive lens exchange. It is implanted in the posterior chamber of the eye to restore visual function following removal of the eye's natural lens.

Who manufactures the Elastimide IOL Model AQ-2010 and where is it made?

The Elastimide IOL Model AQ-2010 is manufactured by Staar Surgical Co., located at 1911 Walker Ave., Monrovia, CA 91016. The device specifications confirm the manufacturer and location as part of the FDA PMA submission records.

Is the Elastimide IOL Model AQ-2010 a single-use or reusable device?

The Elastimide IOL Model AQ-2010 is intended for single-use implantation. As an intraocular lens, it is a sterile, implantable device designed for one-time surgical use and is not intended for reprocessing or reuse after implantation.

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: Staar-Surgical-Co FDA Filings - FDA.report, HaRi · Staar Surgical Co.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Staar Surgical Co.

Sources (1)

  • FDA PMA P910060 23 fields · synced Sep 18, 2026