Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003304724

FEI Number

3003304724

Entity Name

PHYSIOL.S.A

City/State/Country

Liege, BE

Establishment Address

Allee des Noisetiers 4, Liege 4031, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PHYSIOL.S.A (Owner Number: 10094613)

Owner / Operator Contact Address

Allee des Noisetiers 4, Liege, BE-WLG 4031, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P240038

All Registered Proprietary Names

FINEVISION HP Trifocal IOL (POD F GF +11 D) FINEVISION HP Trifocal IOL (POD F GF +27.5 D) FINEVISION HP Trifocal IOL (POD F GF +33.5 D) FINEVISION HP Trifocal IOL (POD F GF +24.5 D) FINEVISION HP Trifocal IOL (POD F GF +20.5 D) FINEVISION HP Trifocal IOL (POD F GF +16 D) FINEVISION HP Trifocal IOL (POD F GF +34 D) FINEVISION HP Trifocal IOL (POD F GF +12.5 D) FINEVISION HP Trifocal IOL (POD F GF +7 D) FINEVISION HP Trifocal IOL (POD F GF +10.5 D) FINEVISION HP Trifocal IOL (POD F GF +30.5 D) FINEVISION HP Trifocal IOL (POD F GF +9 D) FINEVISION HP Trifocal IOL (POD F GF +35 D) FINEVISION HP Trifocal IOL (POD F GF +15.5 D) FINEVISION HP Trifocal IOL (POD F GF +28 D) FINEVISION HP Trifocal IOL (POD F GF +27 D) FINEVISION HP Trifocal IOL (POD F GF +21 D) FINEVISION HP Trifocal IOL (POD F GF +18.5 D) FINEVISION HP Trifocal IOL (POD F GF +26 D) FINEVISION HP Trifocal IOL (POD F GF +31 D) FINEVISION HP Trifocal IOL (POD F GF +32.5 D) FINEVISION HP Trifocal IOL (POD F GF +23 D) FINEVISION HP Trifocal IOL (POD F GF +19.5 D) FINEVISION HP Trifocal IOL (POD F GF +12 D) FINEVISION HP Trifocal IOL (POD F GF +28.5 D) FINEVISION HP Trifocal IOL (POD F GF +8 D) FINEVISION HP Trifocal IOL (POD F GF +29 D) FINEVISION HP Trifocal IOL (POD F GF +17.5 D) FINEVISION HP Trifocal IOL (POD F GF +14 D) FINEVISION HP Trifocal IOL (POD F GF +32 D) FINEVISION HP Trifocal IOL (POD F GF +18 D) FINEVISION HP Trifocal IOL (POD F GF +25.5 D) FINEVISION HP Trifocal IOL (POD F GF +11.5 D) FINEVISION HP Trifocal IOL (POD F GF +19 D) FINEVISION HP Trifocal IOL (POD F GF +26.5 D) FINEVISION HP Trifocal IOL (POD F GF +16.5 D) FINEVISION HP Trifocal IOL (POD F GF +8.5 D) FINEVISION HP Trifocal IOL (POD F GF +23.5 D) FINEVISION HP Trifocal IOL (POD F GF +31.5 D) FINEVISION HP Trifocal IOL (POD F GF +10 D) FINEVISION HP Trifocal IOL (POD F GF +14.5 D) FINEVISION HP Trifocal IOL (POD F GF +30 D) FINEVISION HP Trifocal IOL (POD F GF +9.5 D) FINEVISION HP Trifocal IOL (POD F GF +13 D) FINEVISION HP Trifocal IOL (POD F GF +21.5 D) FINEVISION HP Trifocal IOL (POD F GF +34.5 D) FINEVISION HP Trifocal IOL (POD F GF +22 D) FINEVISION HP Trifocal IOL (POD F GF +24 D) FINEVISION HP Trifocal IOL (POD F GF +20 D) FINEVISION HP Trifocal IOL (POD F GF +29.5 D) FINEVISION HP Trifocal IOL (POD F GF +17 D) FINEVISION HP Trifocal IOL (POD F GF +25 D) FINEVISION HP Trifocal IOL (POD F GF +15 D) FINEVISION HP Trifocal IOL (POD F GF +6 D) FINEVISION HP Trifocal IOL (POD F GF +13.5 D) FINEVISION HP Trifocal IOL (POD F GF +33 D) FINEVISION HP Trifocal IOL (POD F GF +22.5 D) FINEVISION HP Trifocal IOL (POD F GF +6.5 D) FINEVISION HP Trifocal IOL (POD F GF +7.5 D)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2025-12-11
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2025-12-11

Official Correspondent

Denis Hazee

US Agent Details

Silvana Brown Email: regulatory@bvimedical.com Phone: (952) 7377242

Related Public Records

Same Entity

PHYSIOL.S.A

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0275-2012	Abbott Medical Optics Inc (AMO)	3	Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0276-2012	Abbott Medical Optics Inc (AMO)	3	Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0605-2010	Abbott Medical Optics Inc (AMO)	3	AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
Z-0929-2013	Abbott Medical Optics Inc (AMO)	3	AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
Z-2287-2020	Alcon Research LLC Aspex Facility	3	Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.

Similar Registrations

Registration Number	Establishment Name	Location
3012236936	Johnson & Johnson Surgical Vision, Inc.	Irvine, CA, US
2648035	AMO PUERTO RICO MANUFACTURING, INC	ANASCO, PR, US
3015456951	Alcon Laboratories Belgium	Puurs-Sint-Amands Antwerpen, BE
9612169	ALCON LABORATORIES IRELAND LTD.	CORK, IE
3007530141	Alcon Research, LLC	Lesage, WV, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003304724. Last updated year: 2026. Please use registration number 3003304724 when referencing this establishment in official correspondence.