Manual

Main information

  • Trade name:
  • Manual intraocular lens injector, reusable
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Manual intraocular lens injector, reusable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219337
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219337

iNova Pharmaceuticals Australia Pty Ltd - Manual intraocular lens injector, reusable

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

16/01/2014

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. Manual intraocular lens injector, reusable

Product Type

Medical device system

Effective date

16/01/2014

GMDN

47724 Manual intraocular lens injector, reusable

Intended purpose

A 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 lightweight

metal materials (e.g., titanium), has a central plunger that is activated by a precise mechanism (e.g., a

screw thread), and has a mechanism at the distal end to hold/grip the insertion cartridge. This is a

reusable 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 07:54:10 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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