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 . 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 scissors used to cut tissue during plastic A surgery of the (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.

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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 and A Tenon’s capsule on the eye surface to access the . Device intended to be worn directly against the 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.

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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 (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 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.

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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 . A device assembly intended to treat Endoscopic-imaging retinal and other eye disorders, such 37 ophthalmic solid-state laser as , during endoscopic C system cyclophotocoagulation (ECP) procedures. A hand-held, manual, ophthalmic surgical instrument used to cut tissue 38 Enucleation scissors during involving A 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 . 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 (EOM) during an ophthalmic surgical intervention.

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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 . 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.

A very thin and flexible ophthalmic lens intended to be applied to the back 58 Fresnel lens of spectacle lenses to focus light to a A focal point to help manage various vision conditions. A device intended to be applied to spectacle lenses to give a prismatic 59 Fresnel prism A effect typically to manage strabismus or other eye muscle dysfunction. Intended for: ocular laser treatment procedures, including coagulation of abnormal retinal vasculature; and Fundus-imaging ophthalmic capturing real-time digital images of 60 C diode laser system the anterior/posterior eye segments created using colour, and infrared imaging, for diagnosis/treatment planning. Intended to coagulate abnormal Fundus-imaging ophthalmic vascular tissue in the retina and for 61 C solid-state laser system other ocular photocoagulation procedures. A non-bioabsorbable synthetic polymer device designed to be implanted in the supraciliary space (between the ciliary muscle/body and Glaucoma supraciliary 62 the sclera) for the restoration of C implant aqueous humour outflow and subsequent reduction of intraocular pressure as part of treatment for open angle glaucoma. A system designed to transduce radio- frequency (RF) electrical energy from a generator into ultrasound energy, for Glaucoma therapy the extracorporeal application of high 63 C ultrasound system intensity focused ultrasound (HIFU) to the eye, to decrease aqueous humour production and reduce intraocular pressure (IOP) An ophthalmic device designed to produce an image which facilitates 64 Haidinger brush imager A his/her visual function evaluation, particularly the macular integrity. A portable, hand-held device intended 65 Hand-held campimeter for assessing the central 30º visual A field. A device that consists of an arrangement of ophthalmic lenses or 66 Hand-held telescope mirrors with a handle intended to A enlarge images for a visually impaired patient/person.

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A 55 dioptre non-contact diagnostic ophthalmic lens intended for use in the 67 Hruby fundus lens examination of the vitreous body and A the fundus of the eye under slitlamp illumination and magnification. An assembly of portable devices intended to continuously or regularly Implantable intraocular 68 collect and display intraocular C pressure monitoring system pressure (IOP) data for the diagnosis/monitoring of glaucoma. An optical device intended to be implanted into the posterior chamber 69 Implantable prosthesis C of the eye for the reconstruction of partial or total iris defects. An ophthalmic instrument designed to examine the interior of the eye Indirect binocular allowing the examiner to clearly see a 70 A ophthalmoscope wide angle, stereoscopic impression of the details of the fundus (retina) and other structures. An implantable, open-ended circular band designed to flatten the anterior 71 Intracorneal ring corneal curvature, without disturbing C the visual axis, to correct mild and moderate myopia. A hand-held device intended to be used in the home to provide electrical Intranasal lacrimal stimulation to sensory neurons of the 72 C neurostimulator nasal cavities to acutely increase tear production as treatment for aqueous deficient dry eye. An assembly of manually-operated devices designed to reduce the Intraocular pressure-reducing intraocular pressure (IOP) by applying 73 C system a controlled, external, mechanical compression to the surface of the eye in preparation for ophthalmic surgery. An ophthalmic surgical instrument intended to shave tissue from sections 74 Keratome B of the cornea for a lamellar (partial thickness) transplant. A implantable, single-lumen tube intended to provide tear drainage from the front surface of the eye, and also 75 Lacrimal tube C to facilitate saline solution irrigation to a paranasal sinus to manage chronic rhinosinusitis. A hand-held ophthalmic surgical instrument used in ophthalmic surgery 76 Lens spoon A to manipulate/remove the lens of the eye.

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A special ophthalmic trial lens in the form of a rod or series of rods (grooves/cylinders) that changes the 77 Maddox trial lens A size, shape, and colour of an image to dissociate the eyes in the evaluation of eye muscle dysfunction. An optical device intended to enable the patient to see over the top of their 78 Mirror-prism spectacles A head enabling them to look forward in the direction their head is pointing. inducing An ophthalmic device intended to elicit 79 A nystagmus. An ophthalmic device intended to be moved across a patient's field of vision 80 Nystagmus inducing tape A to elicit optokinetic nystagmus and to test for blindness. A hand-held manual ophthalmic measuring instrument consisting of two legs hinged at one end and 81 Ophthalmic calliper A designed to measure the diameter, length, angles, and thicknesses of the eye. A device typically made of a malleable metal (e.g., tantalum), intended to be implanted permanently or temporarily 82 Ophthalmic clip to bring together the edges of a C wound, to aid in healing or to prevent bleeding from small blood vessels in the eye. An assembly of devices designed to apply cold from a gaseous or liquid Ophthalmic cryosurgical 83 refrigerant (cryogen) to a target tissue C system for its destruction and removal during an ophthalmic surgical procedure. An ophthalmic instrument designed to measure the distance between the 84 Ophthalmic distometer A cornea and a spectacle or trial lens (vertex distance). A laser device assembly intended to coagulate abnormal vascular tissue in 85 Ophthalmic dye laser system the retina, and for other C photocoagulation procedures in the eye. A laser device assembly intended for Ophthalmic excimer laser 86 corneal ablation and other C system ophthalmologic procedures. A head-worn ophthalmic device intended to reflect light onto the eye of 87 Ophthalmic head reflector A a patient to allow examination of the eye and its associated structures.

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Intended for the irrigation of the anterior chamber during and other intraocular or Ophthalmic Irrigation extraocular procedures or for the 88 Solution (Balanced Salt irrigation of the conjunctiva following B Solution) application of fluoresceine or for moistening the corneal and conjunctival surface during laser treatment. A laser device assembly intended to coagulate abnormal vascular tissue in Ophthalmic noble gas laser 89 the retina and for other C system photocoagulation procedures in the eye. A component of a modular operating table intended to provide support for and stabilization of the head of the patient (typically includes a headrest) Ophthalmic operating table 90 and to help provide optimal access for A top the surgeon(s) during the intervention (e.g., by having a small-width table top and therefore a shorter stretch distance for the surgeon). A hand-held manual instrument designed to grasp and manipulate Ophthalmic soft-tissue intraocular tissues during ophthalmic 91 B surgical forceps surgery (e.g., anterior segment surgery, vitreo-retinal procedures, , ). A hand-held manual surgical instrument with blades designed to grasp and manipulate a Ophthalmic surgical device 92 nonimplantable invasive ophthalmic A handling forceps surgical device (e.g., ophthalmic cannula, handless iris retractor) and/or for ophthalmic suturing. A hand-held, manual, ophthalmic 93 Ophthalmic suture scissors surgical instrument intended to be A used to cut suture during eye surgery. An ophthalmic, measuring instrument 94 Ophthalmic tonometer designed for determining the B intraocular pressure (IOP). An assembly of devices designed for Ophthalmic ultrasound 95 ophthalmic ultrasound imaging B imaging system procedures. An ophthalmic instrument for determining the proper distance at 96 Ophthalmodiastimeter A which to place prescription lenses for the two eyes. An ophthalmic device intended to be used for testing colour perception by 97 Ophthalmoleukoscope A means of colours produced by polarized light.

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An ophthalmic instrument designed to examine the interior of the eye 98 Ophthalmoscope allowing the examiner to clearly see B the details of the retina and other structures/media. An ophthalmic, device that uses optics 99 Optical pachymeter to measure the thickness of the A cornea. A hand-held ophthalmic surgical instrument used to displace tissue to 100 Orbital depressor facilitate examination of the A surrounding area in the orbital cavity during eye surgery. An implantable ocular device used to reconstruct the floor of the bony cavity that contains the eyeball and its 101 Orbital rim prosthesis C associated muscles, vessels, and nerves and is intended to house an artificial eye. A diagnostic, ophthalmic instrument 102 Perimeter intended for assessing the extent of A the patient's peripheral visual field. A hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate 103 Periocular/lacrimal retractor periocular tissues and/or draw aside A the margins of a periocular surgical wound during an ophthalmic intervention. An assembly of ophthalmic devices intended to deliver energy through a dedicated handpiece tip, which is 104 system C introduced through an incision made in the lens capsule, to perform phacoemulsification. An ophthalmic instrument intended to 105 Phorometer A be used to test ocular balance. A mechanical ophthalmic device that is used during an ophthalmic 106 Phoropter A examination; typically to determine a patient's prescription for glasses. An ophthalmic instrument used for the treatment of eccentric eye fixation (casts in the eye) by dazzling the 107 Pleoptophor A perimacular retina, thereby relatively enhancing the visual capabilities of the fovea. An ophthalmic device used for evaluating hidden (latent) squinting, 108 Polatest i.e., when the patient is not aware of A the condition, and also when it cannot be seen. A sterile implantable device intended 109 Ptosis sling C for the surgical correction of ptosis. Page 10 of 13

A graphic recorder used for recording the response of the pupil to reflected 110 Pupillograph A light. It is used for ophthalmic diagnostic purposes. An ophthalmic instrument used for 111 Pupillometer measuring the width or diameter of the A pupil. A non-bioabsorbable, implantable device designed to permanently fix a 112 Retinal tack detached retina to the underlying C retinal pigment epithelium (RPE) during ophthalmic surgery. A device intended to be implanted on the sclera to compress the eye (scleral 113 Scleral buckling device C buckling) for the surgical treatment of retinal detachment. A device designed for implantation in the sclera to produce expansion by 114 Scleral expansion implant C altering the position of the underlying ciliary muscle. A manual instrument used to indent or imprint the surface of the sclera during 115 Scleral marker B an ophthalmic surgical or perioperative procedure. A hand-held manual ophthalmic surgical instrument that is knife-like in 116 Sclerotome A design and intended to be used to incise the sclera during a sclerotomy. An instrument used for the recording and measuring of the areas of field of 117 Scotometer vision that is reduced, i.e., relative A scotoma, or loss of sensitivity to light (absolute scotoma or blind spots). A pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and 118 Surgical binoculars A provide a magnified image of the visual field during patient examination or surgical intervention. An implantable device formed as a 119 Symblepharon ring circular band used to help prevent the C eyelid from adhering to the eyeball. A ophthalmic device used for the 120 Synoptophor evaluation and training of a patient's A binocular function. An ophthalmic device designed to flash words or images at different 121 Tachistoscope A speeds, for the purposes of ophthalmic diagnostic testing. An ophthalmic device designed to use ultrasound to measure the thickness 122 Ultrasound pachymeter of the cornea, and may in addition be B designed to measure axial length and anterior chamber depth.

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An ophthalmic chart (Snellen chart) 123 Visual chart A used in testing visual . A light viewing box that uses a translucent version of the ophthalmic 124 Visual light box A chart (Snellen chart) used for testing visual acuity. An ophthalmic device intended to 125 Visual projector project an image on a screen to test A visual acuity . An electrical conductor intended to Visual evoked-potential record changes in the electrical 126 A electrode potential for the purpose of measuring visual evoked responses. An assembly of ophthalmic devices intended to deliver energy through a dedicated hand-held instrument, 127 system typically used to treat diabetic vitreous C haemorrhage, retinal detachment, epiretinal membrane, and macular hole. A sterile bag/capsule intended to be implanted in the eye and filled with a fluid (not included) to replace the 128 Vitreous body prosthesis vitreous body and provide C omnidirectional support of the retina for the treatment of severe retinal detachment. An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as 129 Intraocular fluid to maintain anterior chamber depth, C preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment. An intraocular gas is a device consisting of a gaseous fluid intended 130 Intraocular gas C to be introduced into the eye to place pressure on a detached retina. An intraocular lens guide is a device intended to be inserted into the eye 131 Intraocular lens guide during surgery to direct the insertion of B an intraocular lens and be removed after insertion is completed. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, 132 Ophthalmic refractometer B and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.

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A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to 133 Keratoscope observe the corneal reflex. This B generic type of device includes the photokeratoscope and videokeratoscope which records corneal curvature by taking photographs or videos of the cornea. Contact Lens A device designed to insert and 134 A Inserter/Remover remove contact lenses from the eye. A rigid tube designed to create a channel through the sclera for internal ocular access during posterior segment ophthalmic surgery. It is typically made of plastic materials or Ophthalmic working-channel high-grade stainless steel and enables 135 B cannula the introduction of ophthalmic surgical instruments; it may also be used for irrigation (i.e., the infusion of fluids to maintain the interior pressure of the eye during surgery). This is a reusable device.

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