Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1037089

FEI Number

1037089

Entity Name

U.S. IOL, INC.

City/State/Country

LEXINGTON, KY, US

Establishment Address

2500 SANDERSVILLE RD., LEXINGTON, KY 40511, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

U.S. IOL, INC. (Owner Number: 1037089)

Owner / Operator Contact Address

2500 SANDERSVILLE RD., --, Lexington, KY 40511, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K024090

PMA Number

N/A

All Registered Proprietary Names

USIOL Silk Sutures OCCULON HV USIOL Nylon Sutures

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2016-06-07
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2020-03-05
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2020-03-06
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2016-06-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

U.S. IOL, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008641313	FREEDOM OPHTHALMIC PVT LTD	TAMIL NADU, IN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241486	Covidien	Sofsilk Coated Braided Silk Suture	2024-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0530-2015	Abbott Medical Optics Inc (AMO)	3	Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)
Z-2062-2017	Abbott Medical Optics Inc. (AMO)	3	Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
Z-2063-2017	Abbott Medical Optics Inc. (AMO)	3	Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Z-2064-2017	Abbott Medical Optics Inc. (AMO)	3	Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
Z-2065-2017	Abbott Medical Optics Inc. (AMO)	3	Healon 5 Pro, Part No. 10270015

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1037089. Last updated year: 2026. Please use registration number 1037089 when referencing this establishment in official correspondence.