Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004750704

FEI Number

3004750704

Entity Name

AMO UPPSALA AB

City/State/Country

UPPSALA, SE

Establishment Address

RAPSGATAN 7, UPPSALA S-751 36, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Johnson & Johnson Surgical Vision, Inc. (Owner Number: 10053607)

Owner / Operator Contact Address

31 Technology Dr., Suite 200, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P810031

All Registered Proprietary Names

AID, SURGICAL, VISCOELASTIC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2016-12-22

Official Correspondent

Rosanne Melikian

US Agent Details

Rosanne Melikian Business: Johnson & Johnson Vision Email: RegulatoryImplantsMailBox01@its.jnj.com Phone: (714) 3138856

Related Public Records

Same Entity

Johnson & Johnson Surgical Vision, 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
3005675890	OptiMedica Corp.	Milpitas, CA, US
3008169506	TearScience, Inc.	Milpitas, CA, US
3011714173	AMO (HANGZHOU PARK) WAREHOUSE	Hangzhou Zhejiang, CN
9614546	AMO GRONINGEN BV	GRONINGEN, NL
3004178847	AMO (HANGZHOU) CO., LTD.	HANGZHOU Zhejiang, CN

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

Similar Registrations

Registration Number	Establishment Name	Location
3039186269	Nordic Pharma BVG	Siriusdreef, NL
1610287	Alcon Research, LLC	Fort Worth, TX, US
3015456951	Alcon Laboratories Belgium	Puurs-Sint-Amands Antwerpen, BE
3007093114	ANIKA THERAPEUTICS, INC.	Bedford, MA, US
3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004750704. Last updated year: 2026. Please use registration number 3004750704 when referencing this establishment in official correspondence.