ANNEX IISupplementary provisions
ANNEX II Scope 1. This Annex applies to contact lenses listed in Section 1 of Annex XVI to Regulation (EU) 2017/745. Contact lenses containing tools, such as antenna or microchip, contact lenses which are active devices and other items intended to be introduced into or onto the eye are not covered by this Annex. Risk management 2. When carrying out the risk management process provided for in Annex I to this Regulation, as part of the analysis of risks associated with the device, manufacturers shall consider the specific risks listed in Section 3 of this Annex and, where relevant to the device, adopt the specific risk control measures listed in Section 4 of this Annex. 3. Specific risks 3.1. Manufacturers shall analyse and eliminate or reduce as far as possible the risks linked to the following aspects: Design and manufacturing (a) the shape of the device, in particular in view of avoiding irritation by edges or sharps, disconnection or dislocation from the cornea, wrinkling or folding, unequal pressure on the cornea related to positioning; (b) the selection of raw materials for lens, for surface treatments and, if relevant, for lens storage solutions in view of biological safety, biocompatibility, chemical and biological contaminants as well as permeability of oxygen and compatibility with lens storage solutions; (c) biological safety and biocompatibility of the final product, with its packaging and storage solution, including consideration of at least the aspects of cytotoxicity, sensitization, irritation, acute systemic toxicity, subacute toxicity, implantation, sterilization residues and degradation products, extractable and leachable substances. Where the cumulative contact duration is expected to exceed 30 days, aspects of subchronic toxicity, chronic toxicity and genotoxicity shall also be considered; (d) microbiological properties, including bioburden, microbiological contamination of the final device, residual bacterial endotoxins, sterility, contact lens disinfection and preservation; (e) appropriateness of the primary packaging in terms of keeping the lens sterile, permanently covered by storage fluid and avoiding degradation of the product, for example by leaching of container or cover materials, by intrusion of microbial contaminations; (f) the effect of long-term storage and the conditions of storage on the stability and properties of the lens; Distribution chain (a) lack of pre-use testing of suitability of lens wearing performed by ophthalmologist, optometrist, specialised optician or qualified contact lens specialist; (b) lack of expertise of distributors outside the classic optician distribution chain with regard to both the selection of appropriate lenses and their use, storage and safe transport; (c) lack of expertise of distributors outside the classic optician distribution chain with regard to safety or handling advice to the users; User-related hazards/risks (a) lack of experience with and training on the use of contact lenses of certain uses; (b) identification of contra-indications under which contact lenses shall not be used; (c) possible reduced availability to the cornea of tear film and oxygen; (d) lack of hygiene, such as failure to wash and dry hands prior to users placing, using and removing lenses resulting in possible infection, severe inflammation or other diseases of the eye; (e) possible vision hindrance and reduced transmission of light; (f) any possible factors that could cause deterioration of eye sight such as coloration, lack of precise fitting to the eye’s surface and lack of correction; (g) identification of any non-medical conditions under which contact lenses are not be used. Conditions to be considered shall include driving, piloting or operating heavy machinery and water-based activities such as showering, bathing and swimming; (h) increased risk of eye damage if the lenses are worn extensively (for example for long periods, consecutive multiple use); (i) increased risk of eye damage if lenses are still worn when eye redness and irritation occur; (j) the effect of duration of use on any of the risks mentioned above; (k) possible misuse of the primary packaging as containment for storage between several uses; (l) for multiple use contact lenses, risks linked to re-use and irregular re-use by the same consumer; (m) lack of familiarity of consumers with emergency measures in case of any undesirable side-effects. 4. Specific risk control measures (a) The field of vision shall not be reduced by the lens, including in case of reasonably foreseeable dislocation or imprecise placing. The lens shall permit transmission of sufficient light for adequate visibility under any condition of use. (b) All materials of the lens and the inner side of its primary packaging, including its storage solution, shall be biocompatible, non-irritating and non-toxic. In addition, the substances used for colouring of or printing on the contact lenses shall not leach under the intended conditions of use. (c) Lenses and the inner side of their primary packaging, including its storage solution shall be sterile and non-pyrogenic. If in contact with the eye, the storage liquid shall not injure the cornea, eye and the surrounding tissue. (d) Lenses shall be designed so as not to compromise the health of the cornea, eye and surrounding tissue. Lens features such as low oxygen permeability, imprecise placing, dislocation, sharp edges, abrasion, unequal mechanical pressure distribution shall be considered. (e) As regards lenses for multiple use, the manufacturer shall either provide effective maintenance liquids and means for cleaning and disinfecting together with the lens sufficient for the entire lifetime of the lens, or indicate the required maintenance liquids and means for cleaning and disinfecting. The manufacturer shall also either provide or indicate any other equipment or tools for the maintenance and cleaning of the lenses for multiple use. (f) As regards lenses for multiple use, the manufacturer shall validate the maximum number of re-uses and maximum duration of use (for example in hours per day and/or number of days). (g) Manufacturers shall consider whether eye drops need to be used to compensate for dryness. Where such eye-drops are needed, manufacturers shall define criteria to demonstrate their suitability; (h) Manufacturers shall establish a procedure for the identification of any undesirable side-effects by the user and how to deal with them, including reporting to the manufacturer of such undesirable side-effects; (i) The instructions for use and the label shall be designed and written in a manner so that they can be understandable by a lay person and that enables a lay person to use the device safely. Information for safety 5. Label 5.1. The outer packaging intended to be provided to users shall contain the following indications: (a) where devices are intended for single use, in addition to the internationally recognized symbol, in bold font of largest used size on the label the text “Do not re-use”; (b) indication of the dimensions of the lens (outer diameter of the lens and base curve radius); (c) the recommendation to read the instructions for use. 6. Instructions for use 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.