Cataract

Main information

  • Trade name:
  • Cataract extraction/vitrectomy system
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Cataract extraction/vitrectomy system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219136
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219136

Designs for Vision Aust Pty Ltd - Cataract extraction/vitrectomy system

ARTG entry for

Medical Device Included Class IIb

Sponsor

Designs for Vision Aust Pty Ltd

Postal Address

PO Box 77,CAMPERDOWN, NSW, 2050

Australia

ARTG Start Date

13/01/2014

Product category

Medical Device Class IIb

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

D.O.R.C Dutch Ophthalmic Research Centre

(International) B.V

Scheijdelveweg 2

Zuidland, VN, 3214

Netherlands

Products

1. Cataract extraction/vitrectomy system

Product Type

Procedure Pack

Effective date

13/01/2014

GMDN

45072 Cataract extraction/vitrectomy system

Intended purpose

To deliver energies (e.g., ultrasonic, piezoelectric, high frequency current) through

dedicated handpieces and tips that are introduced through an incision or incisions made

in the eye, for the purpose of performing phacoemulsification and/or vitrectomy (the

removal and replacement of cataracts and/or the vitreous in anterior and posterior

segment surgical procedures).

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 08:24:56 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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