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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

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 2 of 123

Device	Model / Reference	Registries	Class	Status
Zcu400i215	ZCU400I215	EUDAMED	Class IIb	Active
Zct3000070	ZCT3000070	EUDAMED	Class IIb	Active
Zct3000275	ZCT3000275	EUDAMED	Class IIb	Active
Zct3000215	ZCT3000215	EUDAMED	Class IIb	Active
Zct4500265	ZCT4500265	EUDAMED	Class IIb	Active
Zct3000130	ZCT3000130	EUDAMED	Class IIb	Active
Zxt300i130	ZXT300I130	EUDAMED	Class IIb	Active
Zct7000085	ZCT7000085	EUDAMED	Class IIb	Active
Zcu400i080	ZCU400I080	EUDAMED	Class IIb	Active
Zct6000070	ZCT6000070	EUDAMED	Class IIb	Active
Zxt300i090	ZXT300I090	EUDAMED	Class IIb	Active
Zct4500310	ZCT4500310	EUDAMED	Class IIb	Active
Zcu400i340	ZCU400I340	EUDAMED	Class IIb	Active
Zct4000165	ZCT4000165	EUDAMED	Class IIb	Active
Zct3000120	ZCT3000120	EUDAMED	Class IIb	Active
Zcu400i075	ZCU400I075	EUDAMED	Class IIb	Active
Zct4500085	ZCT4500085	EUDAMED	Class IIb	Active
Zct8000270	ZCT8000270	EUDAMED	Class IIb	Active
Zct1000150	ZCT1000150	EUDAMED	Class IIb	Active
Zmt300i105	ZMT300I105	EUDAMED	Class IIb	Active
Zmt300i165	ZMT300I165	EUDAMED	Class IIb	Active
Zct7000225	ZCT7000225	EUDAMED	Class IIb	Active
Zmt300i330	ZMT300I330	EUDAMED	Class IIb	Active
Zct7000185	ZCT7000185	EUDAMED	Class IIb	Active
Zct3000300	ZCT3000300	EUDAMED	Class IIb	Active
Zxt300i205	ZXT300I205	EUDAMED	Class IIb	Active
Zct3000260	ZCT3000260	EUDAMED	Class IIb	Active
Zct7000245	ZCT7000245	EUDAMED	Class IIb	Active
Zct7000060	ZCT7000060	EUDAMED	Class IIb	Active
Zct6000315	ZCT6000315	EUDAMED	Class IIb	Active
Zxt300i290	ZXT300I290	EUDAMED	Class IIb	Active
Zxt300i105	ZXT300I105	EUDAMED	Class IIb	Active
Zct3000065	ZCT3000065	EUDAMED	Class IIb	Active
Zmt300i115	ZMT300I115	EUDAMED	Class IIb	Active
Zct1000145	ZCT1000145	EUDAMED	Class IIb	Active
Zcu400i220	ZCU400I220	EUDAMED	Class IIb	Active
Zct6000165	ZCT6000165	EUDAMED	Class IIb	Active
Zct7000095	ZCT7000095	EUDAMED	Class IIb	Active
Zct1000220	ZCT1000220	EUDAMED	Class IIb	Active
Zct7000100	ZCT7000100	EUDAMED	Class IIb	Active
Zct7000300	ZCT7000300	EUDAMED	Class IIb	Active
Zct4000225	ZCT4000225	EUDAMED	Class IIb	Active
Zct3000310	ZCT3000310	EUDAMED	Class IIb	Active
Zcu400i295	ZCU400I295	EUDAMED	Class IIb	Active
Zmt300i140	ZMT300I140	EUDAMED	Class IIb	Active
Zmt300i305	ZMT300I305	EUDAMED	Class IIb	Active
Zct4500250	ZCT4500250	EUDAMED	Class IIb	Active
Zct8000185	ZCT8000185	EUDAMED	Class IIb	Active
Zmt300i125	ZMT300I125	EUDAMED	Class IIb	Active
Zct7000200	ZCT7000200	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.

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.