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Johnson & Johnson Surgical Vision, Inc.

United States·US-MF-000038968

Last updated September 17, 2026

About

We want you to see better. Learn more about eye treatments and solutions for your eye health and vision needs at every stage of life.

Translated from the manufacturer's own website. Source

What Johnson & Johnson Surgical Vision, Inc. makes

The company manufactures posterior-chamber intraocular lenses (IOLs) for pseudophakic use, including single-piece and multifocal designs, as well as intraocular lens-insertion cartridges for surgical implantation. These devices are intended for cataract patients undergoing lens replacement procedures.

The portfolio includes Class IIb and Class III devices, with listings in the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Johnson & Johnson Surgical Vision, Inc. manufacture?

Johnson & Johnson Surgical Vision, Inc. specializes in posterior-chamber intraocular lenses (IOLs) designed for pseudophakic use, which replace the natural lens during cataract surgery. Their portfolio also includes intraocular lens-insertion cartridges, which assist in the precise surgical implantation of these lenses. These devices are tailored for patients undergoing lens replacement procedures to restore vision clarity.

Where is Johnson & Johnson Surgical Vision, Inc. based, and what does that mean for its regulatory oversight?

Johnson & Johnson Surgical Vision, Inc. is based in the United States. This means its devices are subject to regulatory oversight by the FDA (Food and Drug Administration) in the U.S., while their European listings appear in the EU’s eudamed registry, reflecting compliance with EU medical device regulations. The company’s U.S. and EU operations ensure its products meet both regional standards for safety and performance.

Which regulatory registries list Johnson & Johnson Surgical Vision, Inc.’s devices, and why does this matter?

Johnson & Johnson Surgical Vision, Inc.’s devices are listed in the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database. These registries are critical because they provide transparent, searchable records of device details (e.g., model numbers, classifications) for healthcare professionals, regulators, and patients. Listing in these systems ensures traceability and compliance with global medical device reporting requirements.

How are Johnson & Johnson Surgical Vision, Inc.’s intraocular lenses classified under medical device regulations?

Johnson & Johnson Surgical Vision, Inc.’s intraocular lenses fall into Class IIb and Class III categories under medical device regulations. Class III designation applies to higher-risk devices (e.g., those supporting or sustaining life, or posing significant risks if they fail), while Class IIb covers devices with moderate risks, such as certain IOLs. This classification influences manufacturing controls, clinical evaluations, and post-market surveillance requirements to ensure safety and efficacy.

Why do some of Johnson & Johnson Surgical Vision, Inc.’s devices have different model numbers (e.g., ZCT4500140 vs. ZXT300I280), and what do these indicate?

The varied model numbers (e.g., ZCT4500140, ZXT300I280) reflect differences in design, functionality, or intended use within the company’s portfolio. For example, some may represent variations in lens optics (e.g., single-piece vs. multifocal), cartridge compatibility, or surgical application methods. These distinctions are critical for healthcare providers to select the appropriate device for a patient’s specific needs, as they influence outcomes like vision correction and surgical ease.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: Suite 200, 31 Technology Drive, Irvine, United States
Website: www.jjvision.com/
LinkedIn: —
Facebook: facebook.com/JnJVision
Email: [email protected]
Phone: +1 714-227-8729
PRRC Contact: Gary Leaf
EUDAMED SRN: US-MF-000038968
FDA FEI Number: 3012236936
DUNS Number: —

Catalogue (6112)

Page 4 of 123

Device	Model / Reference	Registries	Class	Status
Zxt300i190	ZXT300I190	EUDAMED	Class IIb	Active
Zcu400i085	ZCU400I085	EUDAMED	Class IIb	Active
Zct6000105	ZCT6000105	EUDAMED	Class IIb	Active
Zct1000260	ZCT1000260	EUDAMED	Class IIb	Active
Zct6000305	ZCT6000305	EUDAMED	Class IIb	Active
Zmt300i065	ZMT300I065	EUDAMED	Class IIb	Active
Zct6000055	ZCT6000055	EUDAMED	Class IIb	Active
Zct3000160	ZCT3000160	EUDAMED	Class IIb	Active
Zmt300i265	ZMT300I265	EUDAMED	Class IIb	Active
Zct8000220	ZCT8000220	EUDAMED	Class IIb	Active
Zmt300i340	ZMT300I340	EUDAMED	Class IIb	Active
Zxt300i275	ZXT300I275	EUDAMED	Class IIb	Active
Zmt400i170	ZMT400I170	EUDAMED	Class IIb	Active
Zct4500305	ZCT4500305	EUDAMED	Class IIb	Active
Zmt400i290	ZMT400I290	EUDAMED	Class IIb	Active
Zmt300i080	ZMT300I080	EUDAMED	Class IIb	Active
Zmt300i205	ZMT300I205	EUDAMED	Class IIb	Active
Zct8000335	ZCT8000335	EUDAMED	Class IIb	Active
Zct3000225	ZCT3000225	EUDAMED	Class IIb	Active
Zcu400i225	ZCU400I225	EUDAMED	Class IIb	Active
Zct7000250	ZCT7000250	EUDAMED	Class IIb	Active
Zct4500065	ZCT4500065	EUDAMED	Class IIb	Active
Zcu400i190	ZCU400I190	EUDAMED	Class IIb	Active
Zct4500280	ZCT4500280	EUDAMED	Class IIb	Active
Zct3000200	ZCT3000200	EUDAMED	Class IIb	Active
Zmt300i120	ZMT300I120	EUDAMED	Class IIb	Active
Zmt400i220	ZMT400I220	EUDAMED	Class IIb	Active
Zct4000250	ZCT4000250	EUDAMED	Class IIb	Active
Zct4000325	ZCT4000325	EUDAMED	Class IIb	Active
Zct3000255	ZCT3000255	EUDAMED	Class IIb	Active
Zct4000070	ZCT4000070	EUDAMED	Class IIb	Active
Zmt400i315	ZMT400I315	EUDAMED	Class IIb	Active
Zxt300i255	ZXT300I255	EUDAMED	Class IIb	Active
Zmt300i160	ZMT300I160	EUDAMED	Class IIb	Active
Zct4500165	ZCT4500165	EUDAMED	Class IIb	Active
Zmt400i300	ZMT400I300	EUDAMED	Class IIb	Active
Zmt300i155	ZMT300I155	EUDAMED	Class IIb	Active
Zcu400i065	ZCU400I065	EUDAMED	Class IIb	Active
Zct8000160	ZCT8000160	EUDAMED	Class IIb	Active
Zct4500285	ZCT4500285	EUDAMED	Class IIb	Active
Zxt300i200	ZXT300I200	EUDAMED	Class IIb	Active
Zct3000340	ZCT3000340	EUDAMED	Class IIb	Active
Zct6000265	ZCT6000265	EUDAMED	Class IIb	Active
Zmt400i055	ZMT400I055	EUDAMED	Class IIb	Active
Zmt300i130	ZMT300I130	EUDAMED	Class IIb	Active
Zct4000335	ZCT4000335	EUDAMED	Class IIb	Active
Zct1000170	ZCT1000170	EUDAMED	Class IIb	Active
Zxt300i320	ZXT300I320	EUDAMED	Class IIb	Active
Zct8000155	ZCT8000155	EUDAMED	Class IIb	Active
Zct1000230	ZCT1000230	EUDAMED	Class IIb	Active

Related Companies

Authorised Representatives

AMO Ireland IE

Importers

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Notified Bodies

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Authorities

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FDA Recalls (17)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Johnson & Johnson Surgical Vision, Inc. has 17 recall records initiated between May 9, 2018, and March 14, 2024, with statuses including open, classified, and terminated. The reasons cited involve intraocular lenses with specification deviations (e.g., cylinder axis misalignment, unintended toric marks, or expired distribution), software failures affecting alignment verification, packaging errors (e.g., incorrect cutter sizes or broken irrigation luer components), and manufacturing issues with devices like ophthalmic viscosurgical tools and phacoemulsification systems. Some records mention potential sterility breaches, endotoxin contamination, and nonconforming product releases.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Mar 14, 2024	Z-1755-2024	—	open, classified	Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.
Dec 12, 2023	Z-0735-2024	—	open, classified	Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.
Jul 6, 2023	Z-2289-2023	—	open, classified	Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
Jul 6, 2023	Z-2288-2023	—	open, classified	Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
May 30, 2023	Z-2247-2023	—	open, classified	Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Dec 7, 2022	Z-1006-2023	—	open, classified	Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Dec 7, 2022	Z-1007-2023	—	open, classified	Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Dec 7, 2022	Z-1005-2023	—	open, classified	Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Sep 7, 2022	Z-0169-2023	—	open, classified	Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.
Sep 1, 2022	Z-0086-2023	—	open, classified	As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.
Apr 6, 2022	Z-1033-2022	—	open, classified	Potential breach in the sterility barrier for tray ring covers.
Aug 6, 2021	Z-0028-2022	—	terminated	Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.
Jan 27, 2021	Z-1163-2021	—	terminated	Due to the release of nonconforming Intraocular Lenses (IOLs).
Dec 3, 2019	Z-0867-2020	—	terminated	Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Also, reports of clogging of phacoemulsion equipment tubing, which may lead to delay in the procedure or ocular injury.
Sep 24, 2018	Z-1893-2019	—	terminated	Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement.
Jun 21, 2018	Z-0464-2019	—	terminated	Expired intraocular lenses were distributed.
May 9, 2018	Z-0066-2019	—	terminated	Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI.