Tecnis

Main information

  • Trade name:
  • Tecnis Multifocal 1-piece IOL with Tecnis iTec Preloaded Delivery System - Lens, intraocular, posterior chamber
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Tecnis Multifocal 1-piece IOL with Tecnis iTec Preloaded Delivery System - Lens, intraocular, posterior chamber
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220330
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220330

AMO Australia Pty Ltd - Tecnis Multifocal 1-piece IOL with Tecnis iTec Preloaded Delivery System - Lens,

intraocular, posterior chamber

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

20/02/2014

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. Tecnis Multifocal 1-piece IOL with Tecnis iTec Preloaded Delivery System - Lens, intraocular, posterior

chamber

Product Type

Medical device system

Effective date

20/02/2014

GMDN

35658 Lens, intraocular, posterior chamber

Functional description

The disposable Tecnis iTec Preloaded Delivery System provides both sterile storage of an foldable

multifocal 1pc acrylic lens & a controlled,convenient,touch-free method of folding the IOL prior to delivering

it into the capsular bag of the eye via a minimally invasive insertion tip. The delivery is manually guided by

the surgeon advancing a twist style handpiece. The IOL is intended to be implanted permanently in the

posterior chamber to replace the natural cataractous crystalline lens.

Intended purpose

TECNIS® Multifocal 1-Piece lens is preloaded into the TECNIS iTec Preloaded Delivery System that is

intended to store, fold and assist with insertion of the pre-loaded lens into the capsular bag of the eye.

TECNIS® multifocal foldable acrylic 1-piece intraocular lenses are indicated for primary implantation for

the visual correction of: [1] aphakia in adults in whom a cataractous lens has been removed, and [2]

aphakia following refractive lensectomy in presbyopic adults who may benefit from useful near vision and

reduced spectacle dependence across a range of distances.

Variant information

Diopter +5D to +34.0D in 0.5D increments

Model number (see guidance docs) PMB00

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 04:29:43 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