Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2022

Month: February

Request Number: A-2021-000923

Request Summary: Information regarding the approval of Medical Device License No. 106590 for Acuvue Abiliti (senofilcon A) 1-Day Soft Therapeutic Lenses for Myopia Management which was issued to Johnson & Johnson Vision Care, Inc. (company ID 110950) on 2021-08-25. License Application is requested to identify their device's purpose and intended use as they have publicly indicated that their Acuvue Abiliti has been approved for slowing the progression of myopia in children. Health Canada's approval decision with the approved indications for use is also requested to verify the device''s authorized use for "Therapeutic" and "Myopia Management."

Disposition: Disclosed in part

Number of pages: 81

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