What Is This Device?
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.
What Is FDA Product Code NGY?
Cannula, Trocar, Ophthalmic is FDA product code NGY, Class 1, 21 CFR 886.4350.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
What Do the Recalls Say?
The FDA has recorded 11 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Process control (7) and Device Design (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.