Vortex Surgical, Inc.
Saint Charles, MO, US
Vortex Surgical, Inc. appears in FDA device records in Saint Charles, MO. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 15 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Vortex Surgical, Inc. between 2019 and 2022. The busiest year on record is 2019, with 1. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers | HQB | Substantially Equivalent | |
| K191846 | MAXReach Laser Probe | HQB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013002167 | 3013002167 | Vortex Surgical, Inc. | 4 Research Park Dr, Saint Charles, MO 63304 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HMXCannula, Ophthalmic
- MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
- HNXDepressor, Orbital
- MPAEndoilluminator
- HNRForceps, Ophthalmic
- HNQHook, Ophthalmic
- KDDKit, Surgical Instrument, Disposable
- NTNLed Light Source
- HJKLens, Contact, Polymethylmethacrylate, Diagnostic
- FCWLight Source, Fiberoptic, Routine
- HMQMarker, Sclera
- HQBPhotocoagulator And Accessories
- HJMTransilluminator, Ac-Powered
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1256-2026 | Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker | 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. | Class II | Open, Classified | |
| Z-1255-2026 | Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27 | 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. | Class II | Open, Classified | |
| Z-1254-2026 | Vortex Surgical TID Pharos Illuminated Depressor, VS0801B | XXX | Class II | Open, Classified | |
| Z-1253-2026 | Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 | 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. | Class II | Open, Classified | |
| Z-1252-2026 | Vortex Surgical I2 Injection Kit, VS0500 | 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. | Class II | Open, Classified | |
| Z-1251-2026 | Tecfen Retractable Membrane Polisher, QTPR1267-23 | 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. | Class II | Open, Classified | |
| Z-1250-2026 | Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 | 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. | Class II | Open, Classified | |
| Z-1249-2026 | Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES | 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. | Class II | Open, Classified | |
| Z-1248-2026 | 25GA Subretinal Injection Cannula VS0220.25 | 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. | Class II | Open, Classified | |
| Z-1247-2026 | Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27 | 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. | Class II | Open, Classified | |
| Z-1246-2026 | Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327 | 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. | Class II | Open, Classified | |
| Z-1245-2026 | Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25 | 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. | Class II | Open, Classified | |
| Z-1244-2026 | Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD | 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. | Class II | Open, Classified | |
| Z-1004-2026 | Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; | Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly. | Class II | Open, Classified | |
| Z-0970-2024 | Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain