6.1.

The instructions for use shall contain: (a) in bold font of largest used size in the instructions the text: “Do not re-use”, in addition to the internationally recognized symbol, where devices are intended for single use; (b) a warning “Used lenses shall not be used by other persons”; (c) the indication of the dimensions of the lens (outer diameter of the lens and base curve radius); (d) the indication of the materials of the lens, including its surface and colouring pigments; (e) the indication of water content and oxygen permeability; (f) an indication of the possible effect of incorrect storage conditions on the quality of the product and maximum storage time; (g) instructions on what to do in case of displacement; (h) hygiene measures prior to use (for example washing and drying hands), during use and after use; (i) a warning “Do not contaminate lenses with make-up or aerosols.”; (j) a warning “Do not clean lenses with tap water.”; (k) for multiple use lenses, a detailed description of the cleaning and disinfection procedure, including the description of the necessary equipment, tools and solutions, which shall be named in detail; a description of required storage conditions; (l) for multiple use lenses, the maximum number of re-uses and maximum duration of use(s) (for example in hours per day and/or number of days); (m) where the use of eye drops is recommended, a description of suitable eye drops and the description on how to use them; (n) listing of contraindications under which contact lenses are not to be used. Such a list shall include: dry eyes (inadequate tear fluid), use of eye medication, allergies, inflammation or redness in or around the eye, poor health affecting the eye such as cold and flu, previous medical intervention which may adversely affect the use of the device, any other systemic illness affecting the eye; (o) a warning: “Do not use whilst participating in traffic-related situations (for example driving, riding a bike), operating machinery or whilst undertaking water-related activities such as showering, bathing and swimming.”; (p) a warning: “Avoid activities where possible vision hindrance and reduced transmission of light create a risk.”; (q) a statement regarding increased risk of eye damage in case of continuous wear when eye redness and irritation occur; (r) a warning “Do not use after date of expiry.”; (s) a clear indication of the maximum wearing time; (t) a warning “Do not use lenses beyond maximum wearing time.”; (u) a warning “Do not use lenses during sleeping periods”; (v) a statement on the increased risk of eye damage if the lenses are worn extensively (for example multiple re-uses); (w) a warning “Do not use in excessively dry or dusty environments.”; (x) a warning “Do not re-use the primary packaging as containment for storage between uses.”, where primary packaging is not intended by the manufacturer for such use; (y) a warning: “Do not re-use the storage solution.”; (z) a list of risks linked to ocular health associated with lens wear, as identified by risk analysis, including, if applicable, reduced availability to the cornea of water and oxygen (oxygen transmissibility); (aa) a list of possible undesirable side-effects, their probability of occurrence and their indicators; (bb) instructions on how to deal with complications, including emergency measures; (cc) an instruction “Remove the lens immediately in case of: — irritation or eye pain such as stinging, burning, itching, foreign body sensation; — reduced comfort when compared with previous wearing of an identical lens; — unusual secretions or excessive tear-flow, — redness of the eye, — severe or persistent dryness, — reduced or blurred vision linked to the use of the lens. If any of these symptoms continue after removal of the lens, contact a qualified healthcare professional, such as an ophthalmologist, or an optometrist, authorised by national law to treat such symptoms. The continuation of these symptoms might indicate a more serious condition.”; (dd) information on when and how to report undesirable side-effects to the manufacturer.