Intraocular

Main information

  • Trade name:
  • Intraocular lens-insertion cartridge
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Intraocular lens-insertion cartridge
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217317
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217317

iNova Pharmaceuticals Australia Pty Ltd - Intraocular lens-insertion cartridge

ARTG entry for

Medical Device Included Class IIa

Sponsor

iNova Pharmaceuticals Australia Pty Ltd

Postal Address

PO Box 5033,WEST CHATSWOOD, NSW, 1515

Australia

ARTG Start Date

14/11/2013

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Bausch & Lomb Inc

1400 North Goodman Street

Rochester, New York, 14609

United States Of America

Products

1. Intraocular lens-insertion cartridge

Product Type

Single Device Product

Effective date

14/11/2013

GMDN

47726 Intraocular lens-insertion cartridge

Intended purpose

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.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 02:38:24 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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