Summary for ARTG Entry:
iNova Pharmaceuticals Australia Pty Ltd - Intraocular lens-insertion cartridge
ARTG entry for
Medical Device Included Class IIa
iNova Pharmaceuticals Australia Pty Ltd
PO Box 5033,WEST CHATSWOOD, NSW, 1515
ARTG Start Date
Medical Device Class IIa
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Bausch & Lomb Inc
1400 North Goodman Street
Rochester, New York, 14609
United States Of America
1. Intraocular lens-insertion cartridge
Single Device Product
47726 Intraocular lens-insertion cartridge
A sterile device designed to contain an intraocular lens (IOL), that may have been pre-folded, to facilitate
the insertion (launching) of the folded IOL into the anterior or posterior chamber of the eye through a small
incision during ophthalmic surgery. Commonly known as the cartridge, it is typically made of synthetic
material and is designed as a funnel-shaped tube that terminates at the distal end in a narrowed opening;
the IOL is placed into the wider proximal end. The cartridge is attached to an injector for the insertion, and
is removed from the injector once the IOL has been successfully inserted. This is a single-use device.
No Specific Conditions included on Record
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