iNova Pharmaceuticals Australia - FineVision Intraocular Lens

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by iNova Pharmaceuticals Australia Pty Ltd

I, Simon Waters, Delegate of the Secretary to the Department of Health, on receipt of an application from iNova Pharmaceuticals Australia Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) below for use in advertisements directed to consumers, for the product identified in paragraph (b), provided the condition identified in paragraphs (c) and (d) are met:

1. advertisements are directed to consumers aged 45 and over:

   1. iNova intraocular lenses are used in cataract surgery to replace the natural lens of the eye (or words to that effect);

      and representations to the effect of:

   2. providing a short, simple, accurate and balanced definition of cataracts together with the common symptoms of the condition; and
   3. providing a simple, accurate and balanced description of cataract surgery.
2. 'FineVision Intraocular Lens' (lens, intraocular, posterior chamber - ARTG No. 211587)
3. advertisements for the Device in which any or all of the approved representations are used must contain advisory statements, prominently displayed or communicated, i.e. standing out so as to be easily read from a normal viewing distance and/or heard and understood, to the effect that:
   • extraction of cataracts and replacement with an intraocular lens will require a surgical procedure;
   • any surgical procedure carries risks. Before proceeding, you should seek your eye care professional’s advice; and
   • the Device must be represented in accordance with the primary intended purpose; that is as replacement lens used in cataract surgery. References to achieving spectacle independence through correction of refractive error must be clearly presented as a potential secondary benefit.
4. advertisements for the Device in which references are made to the common symptoms of cataracts must also include the following advisory statement, prominently displayed or communicated, i.e. standing out so as to be easily read from a normal viewing distance and/or heard and understood, to the effect that:
   • these symptoms can also be a sign of other eye problems. If you have any of these symptoms, check with your eye care professional.

Dated this 11th day of July 2017

Simon Waters
Delegate of the Secretary to the Department of Health; and
Manager, Compliance Review & Restricted Representations
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch