Is this your brand? Sign in to claim ownership.

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

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 1 of 123

Device	Model / Reference	Registries	Class	Status
Zct4500140	ZCT4500140	EUDAMED	Class IIb	Active
Zct1000125	ZCT1000125	EUDAMED	Class IIb	Active
Zct4500055	ZCT4500055	EUDAMED	Class IIb	Active
Zct6000185	ZCT6000185	EUDAMED	Class IIb	Active
Zct4500175	ZCT4500175	EUDAMED	Class IIb	Active
Zxt300i280	ZXT300I280	EUDAMED	Class IIb	Active
Zct4000275	ZCT4000275	EUDAMED	Class IIb	Active
Zct8000255	ZCT8000255	EUDAMED	Class IIb	Active
Zct1000185	ZCT1000185	EUDAMED	Class IIb	Active
Zct6000300	ZCT6000300	EUDAMED	Class IIb	Active
Zcu400i180	ZCU400I180	EUDAMED	Class IIb	Active
Zmt400i050	ZMT400I050	EUDAMED	Class IIb	Active
Zct6000135	ZCT6000135	EUDAMED	Class IIb	Active
Zmt300i100	ZMT300I100	EUDAMED	Class IIb	Active
Zcu400i315	ZCU400I315	EUDAMED	Class IIb	Active
Zxt300i285	ZXT300I285	EUDAMED	Class IIb	Active
Zcu400i275	ZCU400I275	EUDAMED	Class IIb	Active
Zmt400i150	ZMT400I150	EUDAMED	Class IIb	Active
Zct4000195	ZCT4000195	EUDAMED	Class IIb	Active
Zct8000150	ZCT8000150	EUDAMED	Class IIb	Active
Zct6000270	ZCT6000270	EUDAMED	Class IIb	Active
Zct8000180	ZCT8000180	EUDAMED	Class IIb	Active
Zcu400i185	ZCU400I185	EUDAMED	Class IIb	Active
Zmt400i175	ZMT400I175	EUDAMED	Class IIb	Active
Zct4500160	ZCT4500160	EUDAMED	Class IIb	Active
Zct7000205	ZCT7000205	EUDAMED	Class IIb	Active
Zct3000185	ZCT3000185	EUDAMED	Class IIb	Active
Zxt300i230	ZXT300I230	EUDAMED	Class IIb	Active
Zct4500180	ZCT4500180	EUDAMED	Class IIb	Active
Zcu400i280	ZCU400I280	EUDAMED	Class IIb	Active
Zct6000285	ZCT6000285	EUDAMED	Class IIb	Active
Zxt300i085	ZXT300I085	EUDAMED	Class IIb	Active
Zct6000325	ZCT6000325	EUDAMED	Class IIb	Active
Zmt300i145	ZMT300I145	EUDAMED	Class IIb	Active
Zct4000105	ZCT4000105	EUDAMED	Class IIb	Active
Zct8000170	ZCT8000170	EUDAMED	Class IIb	Active
Zct6000155	ZCT6000155	EUDAMED	Class IIb	Active
Zcu400i265	ZCU400I265	EUDAMED	Class IIb	Active
Zcu400i175	ZCU400I175	EUDAMED	Class IIb	Active
Zct4500320	ZCT4500320	EUDAMED	Class IIb	Active
Zct7000140	ZCT7000140	EUDAMED	Class IIb	Active
Zxt300i310	ZXT300I310	EUDAMED	Class IIb	Active
Zcu400i285	ZCU400I285	EUDAMED	Class IIb	Active
Zct1000075	ZCT1000075	EUDAMED	Class IIb	Active
Zct8000195	ZCT8000195	EUDAMED	Class IIb	Active
Zct1000315	ZCT1000315	EUDAMED	Class IIb	Active
Zct7000310	ZCT7000310	EUDAMED	Class IIb	Active
Zct6000235	ZCT6000235	EUDAMED	Class IIb	Active
Zcu400i070	ZCU400I070	EUDAMED	Class IIb	Active
Zct4500100	ZCT4500100	EUDAMED	Class IIb	Active

Related Companies

Authorised Representatives

AMO Ireland IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

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.