Device Dossier

INJ100 - Manual intraocular lens injector, single-use

Device Dossier for INJ100 - Manual intraocular lens injector, single-use (Manual intraocular lens injector, single-use, Class IIa, sponsor Bausch &…

Intended purpose

A sterile, hand-held, manual ophthalmic surgical instrument designed to expel (launch) a prepared folded intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic surgery. Commonly known as the handpiece, this device is used to carefully exert pressure on the prepared IOL to push it out of the IOL insertion cartridge. It is typically made of plastic materials and has a central plunger that is activated by a precise mechanism (eg a screw thread), and has a mechanism at the distal end to hold/grip the insertion cartridge. This is a single-use device.

TGA Public Summary