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Johnson & Johnson Vision Care (Australia) Pty Ltd – Soft corrective contact lens - daily-disposable (ARTG 223534), daily-wear (ARTG 223535), extended-wear (ARTG 223536)

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Johnson & Johnson Vision Care (Australia) Pty Ltd

I, Michael Shum, as a delegate of the Secretary to the Department of Health and Aged Care, on receipt of an application from Johnson & Johnson Vision Care (Australia) Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representations described in paragraph (A), for use in advertisements for the product identified in paragraph (B), when the statements identified in paragraph (C) are prominently displayed or communicated[1] in the advertisement in which the restricted representations are used (including on the label and packaging of the goods), subject to the conditions identified in paragraph (D).

(A)

  • ACUVUE contact lenses offer vision correction for people with myopia, hyperopia, astigmatism and presbyopia.

(B)

  • ACUVUE contact lenses - Soft corrective contact lens, daily-disposable - ARTG 223534
  • ACUVUE contact lenses - Soft corrective contact lens, daily-wear - ARTG 223535
  • ACUVUE contact lenses - Soft corrective contact lens, extended-wear - ARTG 223536
    • ACUVUE models include: ACUVUE OASYS MAX 1-DAY, ACUVUE OASYS 1-DAY with HYDRALUXE, 1-DAY ACUVUE MOIST and 1-DAY ACUVUE DEFINE with LACREON, ACUVUE OASYS, ACUVUE OASYS with HYDRACLEAR Plus and ACUVUE VITA brand contact lenses

(C)

  • Your Eye Care Professional will determine which ACUVUE contact lenses are right for you.
  • For eye health, it is important to follow the wear schedule as recommended by your Eye Care Professional.
  • Do not wear contact lenses if you have an eye infection, any disease that may affect the eye, or if you are allergic to any ingredients

together, (the Representations).

(D) 

  • Advertisements in which any one of the Approved Representations is used must comply with the Therapeutic Goods Advertising Code (the Code).

Dated this 20th day of December 2024

Signed electronically

Michael Shum
Delegate of the Secretary to the Department of Health and Aged Care
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch

[1] prominently displayed or communicated, in relation to a statement in an advertisement, means:

  1.  either:

    1. for a visual statement—easily read from a reasonable viewing distance for the particular media type in the context in which the advertisement is intended to be viewed; or

    2. for a spoken statement—able to be clearly heard and understood; and

  2. repeated as often as necessary to be noticed by a viewer or listener.

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