Main information

  • Trade name:
  • Corneal inlay
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Corneal inlay
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222615
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Corneal inlay

ARTG entry for

Medical Device Included Class IIb


Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000


ARTG Start Date


Product category

Medical Device Class IIb



Approval area

Medical Devices


- 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.




AcuFocus Inc

32 Discovery Suite 200 Irvine

, CA, 92618

United States Of America


1. Corneal inlay

Product Type

Single Device Product

Effective date



47959 Corneal inlay

Intended purpose

A sterile implantable device inserted into the natural cornea to treat presbyopia [age-related hyperopia (far

sightedness)]. It is typically made of plastic material and is shaped as a thin annulus (disc) formed to fit the

curvature of the cornea; it includes a central opening that restricts the optical aperture of the eye to

increase depth of field. It is intended for long-term implantation and is surgically inserted in an intrastromal

pocket or flap made by a keratome or an appropriate laser.

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

Public Summary

Page 1 of

Produced at 02.12.2017 at 04:13:37 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.

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There are no safety alerts related to this product.


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