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Vortex Surgical, Inc.

United States·US-MF-000022888

Last updated May 24, 2026

What Vortex Surgical, Inc. makes

Vortex Surgical, Inc. manufactures single-use ophthalmic surgical instruments, including vitrectomy handpieces and cannulas for fluid and gas management, laser beam guides for ophthalmic procedures, and soft-tissue manipulation tools such as forceps and probes. Their portfolio also includes epiretinal/inner limiting membrane scrapers, fibreoptic light instruments, and laser-compatible probes designed for intraocular and retinal surgeries. Additional offerings encompass procedure kits for intraocular injections and illuminated depressors for surgical visualization.

The company’s devices are classified under FDA regulations as Class I, Class II, and Class IIa, with corresponding entries in the FDA’s Unique Device Identifier (UDI) database and the EU’s eudamed registry. These products are intended for use in the United States and European markets, adhering to applicable regulatory standards for surgical and diagnostic ophthalmic instruments.

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 Vortex Surgical, Inc. manufacture?

Vortex Surgical, Inc. specializes in single-use ophthalmic surgical instruments. Their product portfolio includes vitrectomy fluid/gas handling handpieces and cannulas, laser beam guides for ophthalmic procedures, and various soft-tissue manipulation tools like forceps and probes. They also produce epiretinal/inner limiting membrane scrapers, fibreoptic light instruments, and laser-compatible probes. Additionally, they offer procedure kits for intraocular injections and illuminated depressors, all designed for retinal and intraocular surgeries.

Where is Vortex Surgical, Inc. based, and where are their devices listed in regulatory registries?

Vortex Surgical, Inc. is based in the United States. Their devices are listed in two key regulatory registries: the FDA’s Unique Device Identifier (UDI) database and the EU’s eudamed registry. These listings ensure transparency and compliance with regulatory requirements in both the U.S. and European markets.

How are the devices manufactured by Vortex Surgical, Inc. classified under FDA regulations?

The devices produced by Vortex Surgical, Inc. are classified under three categories of FDA regulations: Class I, Class II, and Class IIa. This classification is determined by the level of risk associated with each device, with Class IIa representing a moderate risk that requires special controls to ensure safety and effectiveness. The classification helps guide regulatory oversight and compliance requirements.

What kinds of ophthalmic surgical procedures are Vortex Surgical, Inc.’s devices intended for?

Vortex Surgical, Inc.’s devices are primarily intended for ophthalmic surgical procedures, particularly those involving the retina and intraocular space. This includes vitrectomy procedures (where fluid and gas are managed), laser-assisted surgeries (where beam guides and probes are used), and manipulations of soft tissues like the inner limiting membrane or retinal detachment repairs. Their single-use instruments are designed to enhance precision and reduce infection risk in these delicate procedures.

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

Information

Country: United States
Address: 4, Research Park Dr, Saint Charles, United States
Website: vortexsurgical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 6367784350
PRRC Contact: Andrew Ritts
EUDAMED SRN: US-MF-000022888
FDA FEI Number: —
DUNS Number: 080375891

Catalogue (176)

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Device	Model / Reference	Registries	Class	Status
25ga Flex-Tip Laser Probe- Oertli	VK401115	EUDAMED	Class IIa	Active
27GA MAXReach Laser Probe	VS0140.27	EUDAMEDFDA UDI	Class IIa	Active
25GA Extended MAXReach	VS0141.25	EUDAMED	Class IIa	Active
25ga ACTU8 Talon Pro-Grip	VS0751.25	EUDAMEDFDA UDI	Class IIa	Active
Injection Kit	VS0502C	EUDAMED	Class IIa	Active
23ga ACTU8 Myopic ILM Forceps	VS0744.23-35	EUDAMEDFDA UDI	Class IIa	Active
27GA Curved Laser Probe	VS0120.27	EUDAMEDFDA UDI	Class IIa	Active
27ga ACTU8 ILM Forceps	VS0744.27	EUDAMEDFDA UDI	Class IIa	Active
25GA Curved Laser Probe	VS0120.25	EUDAMEDFDA UDI	Class IIa	Active
23ga ACTU8 ILM Forceps	VS0744.23	EUDAMEDFDA UDI	Class IIa	Active
23ga ACTU8 Myopic Tewari (T2) Forceps	VS0742.23-35	EUDAMEDFDA UDI	Class IIa	Active
27GA Myopic ACTU8 Pro-Grip Forceps	VS0713.27-35	EUDAMED	Class IIa	Active
25GA Straight Laser Probe	VS0110.25	EUDAMEDFDA UDI	Class IIa	Active
23GA ACTU8 Talon End-Grip	VS0753.23	EUDAMEDFDA UDI	Class IIa	Active
25GA Myopic ACTU8 Adaptive Forceps	VS0740.25-35	EUDAMED	Class IIa	Active
25ga ACTU8 Pro-Grip Forceps	VS0713.25	EUDAMED	Class IIa	Active
25ga Flex-Tip Illuminated Laser Probe- Oertli	VK401215	EUDAMED	Class IIa	Active
23GA Extendable MAXReach Laser Probe	VS0141.23	EUDAMED	Class IIa	Active
23ga Flex-Tip Illuminated Laser Probe- Oertli	VK401213	EUDAMED	Class IIa	Active
23GA Myopic ACTU8 Pro-Grip Forceps	VS0713.23-35	EUDAMED	Class IIa	Active
23GA Flex-Tip Laser Probe	VS0130.23	EUDAMEDFDA UDI	Class IIa	Active
25ga ACTU8 End Grip Forceps	VS0743.25	EUDAMED	Class IIa	Active
23ga ACTU8 Talon Pro-Grip	VS0751.23	EUDAMEDFDA UDI	Class IIa	Active
23ga ACTU8 Pro-Grip Forceps Box of 5	VS0743.23	EUDAMEDFDA UDI	Class IIa	Active
23GA ACTU8 Asymmetrical Forceps	VS0745.23	EUDAMEDFDA UDI	Class IIa	Active
27ga Intuitive Extendable MaxReach- Oertli	VK401327	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (15)

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

Vortex Surgical, Inc. has 15 recall records listed in the FDA database, initiated between December 18, 2023, and December 16, 2025. The recalls include open, classified, and terminated statuses, with reasons involving potential voids in sterile pouches, smoothness issues with certain products during cannula passage, and residue found on forceps tips linked to specific lots.

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
Dec 16, 2025	Z-1246-2026	—	open, classified	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Dec 16, 2025	Z-1253-2026	—	open, classified	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Dec 16, 2025	Z-1255-2026	—	open, classified	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Dec 16, 2025	Z-1244-2026	—	open, classified	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Dec 16, 2025	Z-1245-2026	—	open, classified	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Dec 16, 2025	Z-1249-2026	—	open, classified	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Dec 16, 2025	Z-1248-2026	—	open, classified	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Dec 16, 2025	Z-1250-2026	—	open, classified	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Dec 16, 2025	Z-1254-2026	—	open, classified	XXX
Dec 16, 2025	Z-1251-2026	—	open, classified	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Dec 16, 2025	Z-1247-2026	—	open, classified	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Dec 16, 2025	Z-1256-2026	—	open, classified	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Dec 16, 2025	Z-1252-2026	—	open, classified	There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Nov 19, 2025	Z-1004-2026	—	open, classified	Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Dec 18, 2023	Z-0970-2024	—	terminated	Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.