What is FDA product code NGY?

The trocar/cannula set is a manual surgical instrument intended for use as single-use, disposable cannula system for establishing an entry site conduit for passing ophthalmic instruments used to perform posterior ophthalmic surgical procedures.

Unity · Cannula, Trocar, Ophthalmic → Ophthalmic

Name: Unity
Brand: Unity

2manufacturers in China registered for this device type

3catalogue numbers in this listing

Who Else Makes It

All of them in Jiangsu.

Chinese manufacturers registered for FDA product code NGY
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

Regulatory record for Unity
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

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

Catalogue Numbers

Catalogue numbers for Unity
Catalogue number	Size	Status
00380650003959		In distribution
00380650003966		In distribution
00380650004680	27 Gauge	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Alcon	Alcon Laboratories, Inc.	10
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
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.

Recalls naming the identifiers of Unity
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.

Unity