The solid eye sphere is made of medical grade silicone elastomer, It is molded in one piece. The solid eye sphere is available in four sizes 14mm, 16mm, 18mm, & 20mm diameter. The solid eye sphere has been developed and brought to you by surgiwear in collaboration with prominent ophthalmic surgeons of India. Another first from surgiwear. Introduction: Every human being deserves good look. After evisceration the sclera and muscles contract and shrink. The contour of eye is lost. The artificial eye prostheses. Worn later on, will always look artificial due to lack of eye movements. If evisceration had been done in childhood the eye socket may not develop to full size and a bony deformity may occur. The purpose of solid silicone eye sphere is to maintain contour of eye ball. Maintain the eye movements, provide a base for prostheses, maintain shape of eye socket and to prevent bony deformity. Lastly, but not the least to give full self confidence to the patient. It gives excellent cosmetic results. The artificial eye prosthesis, to be worn later on, will look natural due to good eye contour and almost full eye movements. How supplied: The solid eye sphere is supplied in peel open packs, ready to use, sterilized by gamma-rays. Each packet contains one eye sphere. The solid eye sphere is for single use only. Indications:
Solid eye sphere is indicated in all cases where evisceration is done and good cosmetic results are desirable. It can also be used in cases of enucleating where a 11mm rim of sclera with muscles attached has been left. Contraindications: Like all implants, it is contraindicated in cases where active infection or inflammation is present. Preferably it should be inserted after six months to one year of subsidence of inflammation. PE sterilization: The solid eye sphere is for single use only. However it can be re sterilized by autoclaving. Remove perforated eye sphere from packaging. The packaging is not sterilizable. It may be cleaned with sterile distilled water. Do not use any detergent or soap. Pure ethyl alcohol may be used. It may be wrapped in lint free material or directly placed in a small clean metal box. Autoclave it for 30 minutes at 121 Celsius and 1kg/cm pressure. Ethylene oxide sterilization is not recommended. Operative procedure: Insertion of solid eye sphere is done after completion of evisceration of eye and before closure of sclera and conjunctiva. Evisceration is done on standard lines. A proper size of eye sphere is selected. The solid eye sphere is inserted into the sclera cup. The edges of sclera are sutured in a vertical line with interrupted vertical inverting mattress sutures. To avoid "dog ear" projections of sclera at each end of the sutured line. A triangle of sclera is excised from each end with the bases towards the center. An alternative procedure is to make from the limbus four radial scleral incisions about 5mm long at 1.30, 4.30, 7.30 and 10.30 o'clock when eye sphere is in place, tow chromic catgut mattress sutures approximate the medial and ateral scleral flaps and two chromic catgut sutures join the upper and lower flaps. Tenon's capsule is sewn over this with horizontal line of interrupted metric (6/0) chromic catgut sutures and the conjunctiva with continuous key pattern suture of 0.5 metric (8/0) chromic catgut. Post operative management: The patient may be mobilized early. On the first postoperative day the conjunctiva sac is irrigated. The firm pressure dressing is maintained for 2 days, when the socket is dressed. This may be re applied with daily dressing until the fifth day. An acrylic shell may be placed in the conjunctiva sac and a convex black eye shade, lined with sheet of lint, the smooth side opposed to the socket, is applied. The acrylic shell, approximately the shape and size of prostheses to be fitted later, helps to reduce the edema of the conjunctiva and to maintain the appropriate size and shape of the socket. A prosthesis is fitted in the third or fourth week of operation. Pain may be severe for two three days and chemosis may take up to three weeks to subside. Complications: The main complications of use of an eye sphere are infection and expulsion. To prevent infection, use of implant should be avoided with active inflammation. Suitable antibiotic cover should be given during and after implantation. Returned goods policy: Surgiwear will accept this product for replacement or credit. Provided it is returned in unopened and unsoiled packages, unless returned due to a complaint of product or mislabelling. Products will not be accepted for replacement or credit, if they have been in possession of customer for more than 90 days. Determination of product defect and mislabelling will be made by Surgiwear and will be final. Warranty: Surgiwear warrants that device has been manufactured with best quality raw material and reasonable care has been taken in manufacturing of this device. Surgiwear will not be liable for any incidental or consequential loss, damage or expense directly and indirectly arising from use of this device. The liability of Surgiwear is limited to the replacement of the product should. Surgiwear's investigation show that the product was defective at the time of its' shipment. No person has any authority to bind Surgiwear to any representation of warranty concerning this device. Precautions: Products made of silicone elastomer should not come in contact with lint, glove talc, oily residue from skin, oil based soaps, synthetic detergents or other surface contaminants. Use only thick sutures/ligatures for securing silicone products. Silicone has very poor cut strength. Package should be opened only in clean and controlled environment. Avoid unnecessary handing. Instruments coming in direct contact with silicone products should have soft covers. The information given in this brochure is not exhaustive. It is meant for broad guidance only. The surgeon is advised to use the method which his own practice and discretion dictate to be best for the patient.