Blink

Main information

  • Trade name:
  • Blink Intensive Tears PLUS Liquid Gel Eye Drops - Lubricant, eye
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Blink Intensive Tears PLUS Liquid Gel Eye Drops - Lubricant, eye
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219720
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219720

AMO Australia Pty Ltd - Blink Intensive Tears PLUS Liquid Gel Eye Drops - Lubricant, eye

ARTG entry for

Medical Device Included Class III

Sponsor

AMO Australia Pty Ltd

Postal Address

Locked Bag 2005,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

30/01/2014

Product category

Medical Device Class III

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

Abbott Medical Optics Inc

1700 East Saint Andrew Place

Santa Ana, CA, 92705

United States Of America

Products

1. Blink Intensive Tears PLUS Liquid Gel Eye Drops - Lubricant, eye

Product Type

Single Device Product

Effective date

30/01/2014

GMDN

44237 Lubricant, eye

Functional description

A viscous, sterile formulation for installation dropwise, 3-4 times per day into the eyes to lubricate the

corneal surface, increase tear breakup time and relieve dry, gritty and/or tired strained eyes that result

from moderate to severe dry eye syndrome. The multi-dose bottle can be used up to 45 days after

opening.

Intended purpose

To supplement natural tear lubrication of the eyes and provide longer lasting relief from the signs and

symptoms of moderate to severe dry eye syndrome,such as persistent dryness,scratchiness,burning or

irritated uncomfortable eyes. It is presented as a viscous gel drop in a multidose bottle. It is available

over-the-counter (OTC) for home-use. After application, this device cannot be reused.

Variant information

Volume (mL) 2-10 ml

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 06:49:45 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