Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1064514

FEI Number

3004161528

Entity Name

VISIONARY MEDICAL SUPPLIES, INC.

City/State/Country

Madison, WI, US

Establishment Address

6441 Enterprise Ln, Ste 204, Madison, WI 53719, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

VISIONARY MEDICAL SUPPLIES, INC. (Owner Number: 9040860)

Owner / Operator Contact Address

6441 ENTERPRISE LN., Suite 204, Madison, WI 53719, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VisiLens VisiFold VisiFlex Toric VisiLens Aspheric VisiVue EV Toric VisiFlex EV Gold VisiVue EV VisiVision VisiFlex EV VisiVue Multi Piece Foldable VisiVue VisiFlex EV Yellow VisiFlex SUTRALENE SUTRALON Sutrazorb Sutrabond VisiSil VisiSil Plus VisiOctane SUTRASILK VisiTryBlue

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2008-02-22
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2007-05-03
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2008-01-24
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2011-02-09
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2016-02-29
LWL	Fluid, Intraocular	Ophthalmic	Class 3	886.4275	2008-02-22
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2008-01-24
LGY	Trypan Blue	Hematology	Class 1	864.1850	2004-08-12

Official Correspondent

Robert de la Haba Jr.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VISIONARY MEDICAL SUPPLIES, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29
K241486	Covidien	Sofsilk Coated Braided Silk Suture	2024-12-03

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1064514. Last updated year: 2026. Please use registration number 1064514 when referencing this establishment in official correspondence.