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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 3 of 123

Device	Model / Reference	Registries	Class	Status
Zcu400i235	ZCU400I235	EUDAMED	Class IIb	Active
Zct7000150	ZCT7000150	EUDAMED	Class IIb	Active
Zct6000260	ZCT6000260	EUDAMED	Class IIb	Active
Zct1000210	ZCT1000210	EUDAMED	Class IIb	Active
Zmt300i300	ZMT300I300	EUDAMED	Class IIb	Active
Zct6000215	ZCT6000215	EUDAMED	Class IIb	Active
Zxt300i050	ZXT300I050	EUDAMED	Class IIb	Active
Zct8000075	ZCT8000075	EUDAMED	Class IIb	Active
Zct3000210	ZCT3000210	EUDAMED	Class IIb	Active
Zct4500300	ZCT4500300	EUDAMED	Class IIb	Active
Zct4500050	ZCT4500050	EUDAMED	Class IIb	Active
Zxt300i250	ZXT300I250	EUDAMED	Class IIb	Active
Zct4000330	ZCT4000330	EUDAMED	Class IIb	Active
Zct4500070	ZCT4500070	EUDAMED	Class IIb	Active
Zct1000245	ZCT1000245	EUDAMED	Class IIb	Active
Zmt400i080	ZMT400I080	EUDAMED	Class IIb	Active
Zct6000180	ZCT6000180	EUDAMED	Class IIb	Active
Zct7000290	ZCT7000290	EUDAMED	Class IIb	Active
Zct8000145	ZCT8000145	EUDAMED	Class IIb	Active
Zct3000205	ZCT3000205	EUDAMED	Class IIb	Active
Zxt300i185	ZXT300I185	EUDAMED	Class IIb	Active
Zct8000215	ZCT8000215	EUDAMED	Class IIb	Active
Zct3000175	ZCT3000175	EUDAMED	Class IIb	Active
Zct8000310	ZCT8000310	EUDAMED	Class IIb	Active
Zxt300i155	ZXT300I155	EUDAMED	Class IIb	Active
Zct3000240	ZCT3000240	EUDAMED	Class IIb	Active
Zct7000160	ZCT7000160	EUDAMED	Class IIb	Active
Zmt400i120	ZMT400I120	EUDAMED	Class IIb	Active
Zcu400i150	ZCU400I150	EUDAMED	Class IIb	Active
Zct3000165	ZCT3000165	EUDAMED	Class IIb	Active
Zxt300i270	ZXT300I270	EUDAMED	Class IIb	Active
Zct7000165	ZCT7000165	EUDAMED	Class IIb	Active
Zct4000235	ZCT4000235	EUDAMED	Class IIb	Active
Zct4000285	ZCT4000285	EUDAMED	Class IIb	Active
Zct6000110	ZCT6000110	EUDAMED	Class IIb	Active
Zct6000140	ZCT6000140	EUDAMED	Class IIb	Active
Zct7000180	ZCT7000180	EUDAMED	Class IIb	Active
Zcu400i245	ZCU400I245	EUDAMED	Class IIb	Active
Zmt400i110	ZMT400I110	EUDAMED	Class IIb	Active
Zmt400i310	ZMT400I310	EUDAMED	Class IIb	Active
Zcu400i110	ZCU400I110	EUDAMED	Class IIb	Active
Zct7000235	ZCT7000235	EUDAMED	Class IIb	Active
Zmt400i250	ZMT400I250	EUDAMED	Class IIb	Active
Zct7000305	ZCT7000305	EUDAMED	Class IIb	Active
Zct7000125	ZCT7000125	EUDAMED	Class IIb	Active
Zct1000105	ZCT1000105	EUDAMED	Class IIb	Active
Zct4000125	ZCT4000125	EUDAMED	Class IIb	Active
Zct7000285	ZCT7000285	EUDAMED	Class IIb	Active
Zct4000295	ZCT4000295	EUDAMED	Class IIb	Active
Zct1000270	ZCT1000270	EUDAMED	Class IIb	Active

Related Companies

Authorised Representatives

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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.