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Finevision HP Trifocal IOLs

FDA PMAEUDAMED

Class III (US FDA PMA)

PMA P240038

by Beaver-Visitec International, Inc.

Identity

Trade Name
FINEVISION HP Trifocal IOLs FDA PMA
Generic Name
intraocular lens FDA PMA

Identifiers

PMA Number
P240038 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 Finevision HP Trifocal IOL is an intraocular lens designed for primary implantation in the capsular bag of the posterior chamber of the eye. It is indicated for the visual correction of aphakia in adult patients who have undergone cataract removal via phacoemulsification and have less than 1 diopter of pre-existing corneal astigmatism. By mitigating the effects of presbyopia, the lens provides improved intermediate and near visual acuity while maintaining distance visual acuity comparable to a monofocal lens.

This device is manufactured by Beaver-Visitec International, Inc. and is subject to regulatory authorization under FDA PMA and MDD standards. It is intended for use in clinical settings by qualified ophthalmic surgeons. Please consult the product labeling for specific information regarding storage and handling requirements.

Frequently asked questions

What is the primary purpose of the Finevision HP Trifocal IOL?

The lens is indicated for the visual correction of aphakia in adult patients after a cataractous lens has been removed, specifically helping to address presbyopia by improving near and intermediate vision.

Who is a candidate for this intraocular lens?

Candidates are adult patients undergoing cataract surgery who have less than 1 diopter of pre-existing corneal astigmatism and require visual correction for aphakia.

How does this lens compare to a standard monofocal IOL?

While it maintains distance visual acuity comparable to a monofocal IOL, the Finevision HP Trifocal IOL provides the additional benefit of improved intermediate and near visual acuity.

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: FINEVISION HP & HP TORIC - Trifocal hydrophobic IOL, FineVision HP Trifocal IOL - Premarket Approval (PMA) - FDA, [PDF] Clinical Investigation of the Safety and Effectiveness of ..., BVI's FINEVISION HP Trifocal IOL Receives FDA ... - MedPath Trial, FINEVISION HP (POD F GF) - BVI Medical

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Beaver-Visitec International, Inc.
FDA Applicant
Beaver Visitec International, Inc.

Sources (2)

  • FDA PMA P240038 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 17, 2026