Lens, Guide, Intraocular

Which Manufacturers in China Make This?

The one Chinese manufacturer registered for this device type is based in Shanghai.

Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer

What Is FDA Product Code KYB?

Lens, Guide, Intraocular is FDA product code KYB, Class 1, 21 CFR 886.4300.

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 7 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Process design (2), Process control (1) and Mixed-up of materials/components (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Lens, Guide, Intraocular

Unfolder Emerald AR

Model 1CART30 Cartridge

Lens, Guide, Intraocular

Viscoject 2.2 Injector Set

Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures.

Lens, Guide, Intraocular

Lens Exchange Sytem

Lens Exchange System LES G23 three unit package

Lens, Guide, Intraocular

IOL Manipulator – Lester

Positioning of intraocular lens. Angled 10 mm from tip. Tip diameter 0.25 mm.

Lens, Guide, Intraocular

IOL Manipulator – Sinskey

Positioning of intraocular lens. Angled 15 mm from tip. Tip dimensions: diameter 0.20 mm, length 0.50 mm.

Lens, Guide, Intraocular

ONE Series Ultra

ONE Series Ultra Cartridge 30/BOX

Lens, Guide, Intraocular

IOL Glide – Sheets

Placement of intraocular lens into the posterior chamber. Also protects iris from prolapse or trauma during surgical procedures. Thickness 6 mil. End radius 2.5 mm.

Lens, Guide, Intraocular

Nucleus Chopper – Beckingsale

Used to break-up nucleus within capsular bag during phacoemulsification. Angled 11 mm from tip. Tip dimensions: diameter 0.30 mm, length 1.50 mm.

Lens, Guide, Intraocular

Monarch® III

The Monarch® "D" Cartridge is a single-use polypropylene cartridge for posterior chamber IOL delivery

Lens, Guide, Intraocular

Unfolder Emerald

PKG Assy Emeraldt CE Mark Hndpc, 690694

Lens, Guide, Intraocular

Unfolder Platinum 1 Series

Unfolder Platinum 1 Series Crtrdg 30/BOX

Lens, Guide, Intraocular

Surgical Glide

Placement of intraocular lens into the posterior chamber. Also protects iris from prolapse or trauma during surgical procedures. Thickness 6 mil. End radius 1.5 mm.

Lens, Guide, Intraocular

Unfolder Silver

Silver Cartridge Thermoformed TR, 30 BX

Lens, Guide, Intraocular

Nucleus Chopper – P. Koch

Used to break-up nucleus within capsular bag during phacoemulsification. Angled 6 mm from tip. Tip dimensions: diameter 0.30 mm, length 1.50 mm.

Lens, Guide, Intraocular

Bausch + Lomb

Catalogue number AI-28, listed by Bausch & Lomb Incorporated, United States, under Lens, Guide, Intraocular. 1 manufacturer in China is registered for this product code.

Lens, Guide, Intraocular

Duckworth & Kent

The Unfolder Platinum 1 Series Handpiece

Lens, Guide, Intraocular

Viscoject 1.8 Injector Set

Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures.

Lens, Guide, Intraocular

MSI Precision Specialty Instruments

Surgical Glide (Fichman), 30mm Long; 6mm Thick; Phaco Glide 10mm Long x 2.6mm Wide, Tapered To 1.75mm, IOL Glide Portion; 20mm Long x 5mm Wide, 2.5mm Radius, Box Of 50

Lens, Guide, Intraocular

Monarch® II

The Monarch® "B" Cartridge is a single-use polypropylene cartridge for posterior chamber IOL delivery

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer