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

Public Summary
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

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