Summary for ARTG Entry:
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
AMO Australia Pty Ltd
Locked Bag 2005,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class III
- 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.
Abbott Medical Optics Inc
1700 East Saint Andrew Place
Santa Ana, CA, 92705
United States Of America
1. Tecnis Multifocal 1-piece IOL with Tecnis iTec Preloaded Delivery System - Lens, intraocular, posterior
Medical device system
35658 Lens, intraocular, posterior chamber
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.
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:  aphakia in adults in whom a cataractous lens has been removed, and 
aphakia following refractive lensectomy in presbyopic adults who may benefit from useful near vision and
reduced spectacle dependence across a range of distances.
Diopter +5D to +34.0D in 0.5D increments
Model number (see guidance docs) PMB00
No Specific Conditions included on Record
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