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Appendix A File No. 29/Misc/03/2020-DC(187) Drugs Controller General (India) Directorate General of Health Services FDA Bhawan, Kotla Road, New Delhi. Notice Classification of Medical Devices Pertaining to Ophthalmology S. Risk Device Name Intended Use No. Class An ophthalmic device intended to measure the time required for retinal 1 Adaptometer B adaptation and the minimum light threshold. An ophthalmic device intended to 2 Amsler grid rapidly detect central and paracentral A irregularities in the visual field. A ophthalmic instrument used to test a patient for abnormal red/green colour 3 Anomaloscope A vision by differentiating the red/green colour vision defects. A collection of sterile devices, Aqueous/vitreous humour including a fluid or semifluid 4 D replacement medium kit substance, used in combination to replace the fluid of the eye. An ophthalmic instrument designed to measure the focusing power (dioptric Automated 5 power) and other optical A lensmeter(Dioptometer) characteristics of a spectacle lens, contact lens, or prism. An ophthalmic plane lens, intended to 6 Bagolini lens determine harmonious/anomalous A retinal correspondence. An ophthalmic device for binocular 7 Binocular vision test unit A vision testing. A hand-held, manual, ophthalmic surgical instrument intended to be 8 Blepharoplasty scissors used to cut eyelid tissue during plastic A surgery of the eyelids (blepharoplasty). A device intended to be permanently implanted in the posterior chamber of the eye for correction and fixation of a 9 Capsular bag anchor C subluxated capsular bag, typically in association with in-the-bag intraocular lens (IOL) implantation. Page 1 of 13 An ophthalmic lamp, used to test a 10 Colour discrimination tester person's ability to differentiate A between colours. Colour-discrimination eye 11 Intended for testing colour vision. A chart A hand-held, manual, ophthalmic surgical instrument intended to be 12 Conjunctival scissors used to cut the conjunctiva and A Tenon’s capsule on the eye surface to access the sclera. Device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct Contact Lens (Including 13 vision conditions or act as a B Coloured Contact Lens) therapeutic bandage or/and to change the appearance of the eye for decorative purposes. An assembly of devices used to clean Contact lens agitation and disinfect contact lenses through 14 B cleaning system automated or manual mechanical agitation . An aqueous formulation containing appropriate agents for loosening Contact lens disinfecting 15 debris from contact lenses, and that B solution contains a disinfectant intended to act on contact lens. A formulation of proteolytic enzymes, Contact lens protein-removal used to remove debris and protein 16 B solution deposits from reusable contact lenses, or to remove protein deposits only. A measuring instrument used in 17 Contact lens radius gauge ophthalmology to determine the radius A of curvature of contact lenses. A unit intended to disinfect or sterilize 18 Contact lens thermal cleaner reusable soft contact lenses by means B of heat. A hand-held, ophthalmic surgical Corneal burr manual 19 instrument, used to excavate corneal B instrument tissue through manual rotation. An assembly of devices designed for 20 Corneal burr system abrasion of the cornea and other eye B tissues. A device designed for abrasion of the cornea to polish corneal scratches 21 Corneal burr, abrasion and/or the pterygium bed after surgical B removal, and/or for abrasion of lid margin lesions. A device designed for gentle removal Corneal burr, rust ring of rust stains (rust rings) from the 22 B removal cornea after the extraction of a ferrous foreign object. Page 2 of 13 Intended to create a number of small perforations in the epithelial layer of the cornea through which riboflavin 23 Corneal epithelium perforator can pass into the cornea during B corneal collagen crosslinking, to treat corneal ectasia (typically keratoconus). Intended to create a circular cut through the epithelial layer of the cornea to create an epithelial flap 24 Corneal epithelium trephine intended to be folded back during B laser assisted epithelial keratomileusis (LASEK) surgery, after which the flap is replaced. A implantable device inserted into the Corneal inlay, aperture 25 natural cornea to treat presbyopia C reducing based on aperture reduction. A implantable device inserted into the Corneal inlay, cornea- 26 natural cornea to treat refractive errors C reshaping by reshaping the cornea. A device, typically made of a non- abrasive fluid-absorbing material that is placed on the surface of the cornea 27 Corneal light shield B to shield the retina from excessive illumination during an ophthalmic procedure. A manual instrument intended to be used to imprint, indent, and/or incise 28 Corneal marker B corneal tissue prior to an ophthalmic surgical procedure. A device designed to hold donated corneal tissue so that it can be 29 Corneal resection holder B resected in preparation for transplantation. A hand-held, manual, ophthalmic 30 Corneal scissors surgical instrument intended to be B used to cut corneal tissue. A mechanical eye shield made of 31 Corneal shield collagen that is placed on the eye to B protect the cornea. A hand-held, manual ophthalmic surgical instrument designed to excise 32 Corneoscleral punch a segment of tissue from the sclera or B cornea of a patient or from grafts taken from cadaver donors. An ophthalmic lens used in binocular indirect ophthalmoscopy to focus 33 Diagnostic condensing lens A reflected light from the fundus of the eye. A receptacle intended to maintain, transport, and facilitate clinical 34 Donor cornea container examination of a donated cornea C during the period between cornea collection and transplantation surgery. Page 3 of 13 An ophthalmic instrument for 35 Eikonometer A diagnosing aniseikonia. An ophthalmic device designed to test Electronic occlusion and train vision for conditions where 36 A spectacles decreased visual acuity may be due to unequal vision in the eyes. A device assembly intended to treat Endoscopic-imaging retinal and other eye disorders, such 37 ophthalmic solid-state laser as glaucoma, during endoscopic C system cyclophotocoagulation (ECP) procedures. A hand-held, manual, ophthalmic surgical instrument used to cut tissue 38 Enucleation scissors during eye surgery involving A enucleation of the eye and/or its related structures. A hand-held manual surgical instrument intended to be used during posterior segment surgery to lift the Epiretinal/inner limiting inner limiting membrane (ILM) and/or 39 B membrane scraper an epiretinal membrane (ERM), and which may have additional posterior segment membrane manipulation uses. A modified ophthalmoscope that projects a bright light encompassing 40 Euthyscope an arc of approximately 30 degrees on A the fundus of the eye for the treatment of amblyopia. An ophthalmic instrument used to 41 Exophthalmometer A measure the degree of exophthalmos. A receptacle designed to fit around the eye socket and which is filled with 42 Eye cup warm water or an eyewash solution A and placed over the eye to allow the liquid to wash the affected eye. A device intended to be placed over closed eyes to apply heat for the treatment of meibomian gland 43 Eye heat therapy pack B dysfunction (MGD), dry eye syndromes, blepharitis and other related ocular conditions. A device intended to be used with an eye irrigation kit/system to direct 44 Eye irrigation shield irrigation solution to the surface of the A eye and allow the solution to gently lavage the surface of the eye. An hand-held manual ophthalmic surgical instrument designed to 45 Eye muscle clamp atraumatically grasp and hold the B extraocular muscles (EOM) during an ophthalmic surgical intervention. Page 4 of 13 An implantable device made from 46 Eye muscle sleeve synthetic materials that is used to C encase or isolate an ocular muscle. A sterile, cushion-like device intended 47 Eye pad to protect the eye or to absorb eye A secretions. A hand-held, manual, ophthalmic surgical instrument intended to be 48 Eye spud used to remove a foreign body/object A embedded in or adhering to the surface of the eye globe. An implantable device designed to regulate the flow of fluid between the anterior chamber and the space 49 Eye valve C around the conjunctiva of the eye by allowing flow when the pressure in the chamber is above a pre-set value. A hand-held manual surgical instrument designed to atraumatically 50 Eyelid clamp A grasp and hold the eyelid during an ophthalmic surgical intervention. An ophthalmic device that is applied to the outside of the upper eyelid to 51 Eyelid weight, external A "lidload" the eyelid to restore upper eyelid muscle function. An ophthalmic device that is implanted subcutaneously within the upper 52 Eyelid weight, implantable C eyelid to "lidload" the eyelid to restore upper eyelid muscle function. A black tangent screen intended for assessing the extent of the patient's peripheral visual field by mapping the 53 Felt tangent screen A visual response to a test object moved from the periphery towards the centre of the screen. A device assembly in which input energy is used to excite a glass/crystal Femtosecond ophthalmic 54 rod to emit a high-power laser beam C solid-state laser system intended for ocular resections and incisions. A hand-held manual surgical instrument inserted into the eye during surgical intervention to manipulate Fibreoptic general-purpose 55 anatomical structures or foreign A ophthalmic hook bodies within the eye and simultaneously conduct a field of cold light to illuminate the surgical site. A circular band, sutured to the sclera 56 Flieringa ophthalmic ring to prevent collapse of the globe during A difficult intraocular operations. A manually-operated, ophthalmic device intended to provide indirect 57 Fornixscope A access and viewing of the upper conjunctival fornix and inner surface of Page 5 of 13 the eyelid as an alternative to eyelid eversion.
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