Who else makes this device?

Name: Viscoject 1.8 Injector Set
Brand: Viscoject 1.8 Injector Set

Ophthalmic › SurgicalLens, Guide, Intraocular

Viscoject 1.8 Injector Set

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

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code KYB
Manufacturer	City	Province	Registered as	Device types
Shanghai Medical Instruments (Group) Ltd. Corp.	Shanghai	Shanghai	Contract manufacturer	235

Record

Regulatory record for Viscoject 1.8 Injector Set
Listed by	Medicel AG, Switzerland
FDA product code	KYB
Device type	Lens, Guide, Intraocular
Device class	Class 1
Regulation	21 CFR 886.4300
Establishment	Contract manufacturer, Manufacturer
510(k)	K070669
Record published	2026-04-28

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Viscoject 1.8 Injector Set
Catalogue number	Size	Status
LP604350		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Duckworth & Kent	Duckworth AND Kent Limited	5
Unfolder Emerald	Johnson & Johnson Surgical Vision, Inc.	3
Monarch® II	Alcon Laboratories, Inc.	2
MSI Precision Specialty Instruments	MED Saver, Inc.	2
Unfolder Silver	Johnson & Johnson Surgical Vision, Inc.	2
Monarch® III	Alcon Laboratories, Inc.	2
IOL Manipulator – Sinskey	Hurricane Medical	2
Lens Exchange Sytem	Visioncare Ophthalmic Technologies Ltd.	2
Bausch + Lomb	Bausch & Lomb Incorporated	1
Nucleus Chopper – P. Koch	Hurricane Medical	1
Surgical Glide	Hurricane Medical	1
Unfolder Platinum 1 Series	Johnson & Johnson Surgical Vision, Inc.	1

Showing 12 of 18. All products under Lens, Guide, Intraocular

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K070669	2007-11-01

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.