Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012236936

FEI Number

3012236936

Entity Name

Johnson & Johnson Surgical Vision, Inc.

City/State/Country

Irvine, CA, US

Establishment Address

31 Technology Drive, Suite 200, Irvine, CA 92618, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,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

K060366

PMA Number

N/A

All Registered Proprietary Names

LENS, MULTIFOCAL INTRAOCULAR Unit, phacofragmentation Accessories, soft lens products Unit, phacofragmentation Unit, phacofragmentation Unit, phacofragmentation LENS, GUIDE, INTRAOCULAR Keratome, ac-powered Powered laser surgical instrument Accessories, soft lens products Unit, phacofragmentation IMPLANT, EYE VALVE Unit, phacofragmentation Vitrectomy, instrument cutter Accessories, soft lens products Device, irrigation, ocular surgery IMPLANT, EYE VALVE intraocular lens Instrument, vitreous aspiration and cutting, battery-powered Ophthalmic femtosecond laser Accessories, soft lens products Case, Contact Lens Ultrazyme Unit, phacofragmentation AID, SURGICAL, VISCOELASTIC ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Sterilization tray Ophthalmic femtosecond laser Unit, phacofragmentation AID, SURGICAL, VISCOELASTIC Accessories, soft lens products Case, Contact Lens Unit, phacofragmentation Excimer laser system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2016-12-22
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2019-10-17
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2016-12-22
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2016-12-22
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2016-12-22
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2016-12-22
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2016-12-22
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2021-03-15
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
KYF	Implant, Eye Valve	Ophthalmic	Class 2	886.3920	2016-12-22
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	Class 2	886.4150	2016-12-22
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2016-12-22
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2016-12-22
KYF	Implant, Eye Valve	Ophthalmic	Class 2	886.3920	2016-12-22
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2016-12-22
POE	Extended Depth Of Focus Intraocular Lens	Ophthalmic	Class 3	886.3600	2016-12-22
MJP	Lens, Intraocular, Toric Optics	Ophthalmic	Class 3	886.3600	2016-12-22
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2016-12-22
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2016-12-22
HKP	Instrument, Vitreous Aspiration And Cutting, Battery-Powered	Ophthalmic	Class 2	886.4150	2016-12-22
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2016-12-22
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2016-12-22
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2018-05-11
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2016-12-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-12-22
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2017-04-18
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2016-12-22
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2016-12-22
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2016-12-22
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22
LZS	Excimer Laser System	Unknown	Class 3	N/A	2016-12-22
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-12-22

Official Correspondent

Rosanne Melikian

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Johnson & Johnson Surgical Vision, Inc.

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

View Entity Profile →

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3011714173	AMO (HANGZHOU PARK) WAREHOUSE	Hangzhou Zhejiang, CN
9614546	AMO GRONINGEN BV	GRONINGEN, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K091915	Lenstec, Inc.	FLUID ISOLATION DEVICE	2009-10-27
K830812	Alphamedix, Inc.	ALPHAMEDIX I/A HAND-PIECE, 500-001	1983-06-08
K133115	Abbott Medical Optics, Inc.	COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK	2014-02-27
K121721	Abbott Medical Optics, Inc.	LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)	2012-10-15
K111697	Abbott Medical Optics, Inc.	AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM	2011-09-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1670-2013	Abbott Medical Optics, Inc.	2	Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Z-0099-2024	Alcon Research, LLC	2	Constellation Vision System, REF: 8065751150
Z-0305-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-1794-2020	Alcon Research LLC	2	Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
Z-2109-2025	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012236936. Last updated year: 2026. Please use registration number 3012236936 when referencing this establishment in official correspondence.