Alcon
Alcon’s valved short entry system is a single-use accessory for vitrectomy surgery that interfaces with Alcon surgical consoles. The entry system provides a port through which vitreoretinal…
Alcon’s valved short entry system is a single-use accessory for vitrectomy surgery that interfaces with Alcon surgical consoles. The entry system provides a port through which vitreoretinal instruments access the eye while the valve helps maintain the surgical interface.
The filed example is supplied as a three-count configuration. Alcon lists multiple entry-system variants, so gauge, length and pack quantity belong to this example only.
Listed Item
27GA High Performance Valved Short Entry System, 3 mm 3 Count
Surgical Console Interface
The entry device functions as an access port in the vitrectomy workflow and connects with a compatible surgical console. The valve is part of the system’s interface design.
The listed 27-gauge configuration is one accessory variant within Alcon’s entry-system family. Other versions differ in configuration and are not described by this item.
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Victor Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Alcon Laboratories, Inc., United States |
|---|---|
| FDA product code | NGY |
| Device type | Cannula, Trocar, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2025-04-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 12, box of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00380650003560 | In distribution | |
| 00380650003553 | In distribution | |
| 00380650003522 | 25 Gauge | In distribution |
| 00380650003508 | In distribution | |
| 00380650003591 | In distribution | |
| 00380650003539 | 27 Gauge | In distribution |
| 00380650003584 | In distribution | |
| 00380650003492 | In distribution | |
| 00380650004673 | In distribution | |
| 00380650004703 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cannula, Trocar, Ophthalmic | Microvision, Inc. | 7 |
| Mani Infusion Cannula | Mani, Inc. | 6 |
| Ophthalmic trocar | FCI S A S FCI 20 22 | 4 |
| Mani Trocar | Mani, Inc. | 3 |
| Unity | Alcon Laboratories, Inc. | 3 |
| Mani Trocar Kit | Mani, Inc. | 3 |
| Rumex | Rumex International Co. | 3 |
| Disposable one step single cannula including inserter. (25 gauge / 0.5 mm) | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 3 |
| 23G High Flow infusion line | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 2 |
| 27G High Flow infusion line | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 2 |
| Universal silicone infusion line for 20 gauge/0.9 mm cannula system. | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 2 |
| 25G Cannula set with High Flow infusion line | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 2 |
Showing 12 of 52. All products under Cannula, Trocar, Ophthalmic
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Alcon Research, LLC | UDI-DI | 2025-08-05 | Class II | Process control | Due to incomplete seals in the pouch which provide the sterile barrier. | 1632 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.