The UNFOLDER Silver Series Implantation System

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1 The UNFOLDER Silver Series Implantation System Z Rev. D EN Revision Date: 02/2012 Description The UNFOLDER Silver Series Implantation System consists of the following components: The UNFOLDER Silver Series Cartridge, Silver Series SofTip Sheath, and Silver Series SofTip Applicator; Model PSCST The UNFOLDER Silver Series Handpiece Model PSHST, Model SILVERT, or Model SILVERZ The UNFOLDER Silver Series Cartridge is provided sterile and non-pyrogenic and is designed for single use only (Fig. 1). The Silver Series SofTip Sheath and Silver Series SofTip Applicator are provided sterile and non-pyrogenic and are designed for single use only (Fig. 2). The UNFOLDER Silver Series Handpiece (Fig. 3 and Fig. 4) are provided non-sterile and reusable. The UNFOLDER Silver Series Implantation System is designed for use with CLARIFLEX, PHACOFLEX II, CeeOn, TECNIS Silicone, and ARRAY Silicone 24.0 D IOLs only. Indication For Use The UNFOLDER Silver Series Implantation System is used to fold and assist in inserting CLARIFLEX, PHACOFLEX II, CeeOn, TECNIS Silicone, and ARRAY Silicone 24.0 D IOLs only, into the eye. Contraindications: None. RX Only - In the U.S., prescription only device. Instructions for Reprocessing 1. The UNFOLDER Silver Series Handpieces must be thoroughly cleaned and sterilized before each use. Before cleaning and sterilizing the handpiece, ensure that the Silver Series SofTip Sheath and The UNFOLDER Silver Series Cartridge are removed from the handpiece and discarded. The UNFOLDER Silver Series Cartridge, Silver Series SofTip Sheath, and Silver Series SofTip Applicator are intended for single use only. Discard after a single use. Do not autoclave or resterilize by any method. 2. The UNFOLDER Silver Series Handpiece should be ultrasonically cleaned at least once per day and manually cleaned before each surgery. ULTRASONIC DAILY CLEANING: Rinse the handpiece vigorously with demineralized or distilled water. Clean the handpiece with a mild soap solution and gently scrub with a soft bristle brush paying particular attention to the inside, and the rod of the instrument. Thoroughly rinse and flush the handpiece vigorously with demineralized or distilled water. Ultrasonically clean the instrument for a minimum of 5 minutes using demineralized or distilled water. Follow the instructions supplied by the manufacturer of the ultrasonic cleaning bath. After ultrasonic cleaning, thoroughly flush and rinse the instrument under running water and then do a final rinse using demineralized or distilled water. The handpiece should be dried with a hot air blower or lint-free cloth before returning to storage. MANUAL CLEANING: Immediately after every surgery rinse the handpiece with demineralized or distilled water. Clean the handpiece with a mild soap solution and gently scrub with a soft bristle brush paying particular attention to the inside area and the rod of the instrument. Thoroughly flush the instrument under running water and then do a final rinse using demineralized or distilled water. The handpiece should be dried with a hot air blower or lint-free cloth before returning to storage. GENERAL CARE ITEMS: Ultrasonically clean the handpiece at least once per day. New handpieces are provided non-sterile and must be ultrasonically cleaned prior to use. Do not allow blood, tissue, or saline to dry on the instrument. Never use saline (balanced salt solution) for rinsing the instrument. Always use demineralized or distilled water for final rinsing. Do not use metal brushes or abrasive powders to clean the instrument.

2 Always ensure the front and back portions of the handpiece are screwed together tightly before use. To expose the entire rod, the handpiece can be disassembled by unscrewing the front and back portions of the handpiece. The two portions of the handpiece must be screwed together tightly prior to use. 3. Steam sterilize The UNFOLDER Silver Series Handpiece according to one of the following methods: Gravity displacement cycle suitable for wrapped items at 270 F-275 F (132 C 135 C) for 15 minutes, or Prevacuum cycle consisting of wrapped items at 270 F-275 F (132 C 135 C) for 4 minutes. Please reference the ANSI/AAMI ST79: 2006 Guideline Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, Section 8.6.1, Sterilization Parameters for Wrapped or Containerized Item. 4. Prior to each use, perform the following test to assure The UNFOLDER Silver Series Handpiece is in Proper working condition. Fully advance the rod tip to assure there is no resistance associated with the advancement of the rod. Visually inspect the rod tip and screw threads to establish that there is no damage or mineral deposits. Do not use the handpiece if the tip appears bent, nicked, or damaged in any way. The tip should resemble the diagram in Fig AMO has validated the above reprocessing methods to ensure that they will produce a sterile instrument. The user is responsible for qualifying any method that deviates from AMO s recommended method of cleaning and sterilizing The UNFOLDER Silver Series Handpiece. Instructions For Use Read the entire instructions before using this device. 1. Sterilize The UNFOLDER Silver Series Handpieces according to the method specified under Instructions For Reprocessing. Sterility assurance is the responsibility of the user. 2. If using the technique that requires synchronous rotation of the screw mechanism and handpiece body to deliver the IOL, confirm that the handpiece (fine threads on screw mechanism) is engraved with the designation MODEL PSHST (Fig. 3). If using the twist technique, that only requires rotation of the handpiece body while not rotating the screw mechanism to deliver the IOL, confirm that the handpiece (coarse threads on screw mechanism) is engraved with the designation MODEL SILVERT or MODEL SILVERZ (Fig. 4). 3. Ensure that the sterilized, outer sealed tray contains the inner tray which holds one The UNFOLDER Silver Series Cartridge and one Silver Series SofTip Sheath and Silver Series SofTip Applicator. Remove the inner tray from the sealed tray. 4. Fully advance the handpiece rod through the end of the handpiece to expose the rod tip. Grasp the inner tray which contains the Silver Series SofTip Applicator and insert the handpiece rod tip into the Silver Series SofTip Sheath until it stops. Remove the rod tip from the Silver Series SofTip Applicator. Visually examine the rod tip to ensure that the Silver Series SofTip Sheath is fully engaged on the rod tip as shown in Figure 6. The Silver Series SofTip Sheath may be seated on the rod tip using sterile-gloved fingers. If necessary, the Silver Series SofTip Sheath may be removed from the applicator using forceps and place on the rod tip manually. Retract the rod tip from the inner tray. Ensure the rod is fully retracted before attempting to install the cartridge. Do not use The UNFOLDER Silver Series Implantation System if the Silver Series SofTip Sheath is not fully seated on the rod of the handpiece. Note: Full engagement is achieved when the proximal end of the Silver Series SofTip Sheath is seated against the shoulder of the rod tip (Fig. 6a). 5. With the cartridge still in the inner tray, inject viscoelastic into the tube of the cartridge (Fig. 7a) and a small amount of viscoelastic along the bottom of both sides of the troughs from the tube mouth (Fig. 7b) back to the IOL seating position but no further (Fig. 7c). Place the lens anterior side up across the central hinge of The UNFOLDER Silver Series Cartridge. The IOL must be positioned as shown in the IOL diagram on the cartridge wing (Fig. 7d), so that it is aligned with the drawing on the cartridge wing (Fig. 7e). Avoid applying viscoelastic to the upper surface of the IOL or to the Silver Series SofTip Sheath. 6. Using rounded blade forceps, push the optic edges down into the tube portion of the wings and push the center of the lens optic down as the wings are closed. The optic edge or the haptics of the IOL should not be pinched by the wings when they are closed. The leading haptic should be visible with

3 its tip pointing forward in the tube portion of the cartridge. Do not allow the leading haptic to be folded back. The tip of the leading haptic should be straight. The trailing haptic should extend out the back of the cartridge. If either of the haptics are caught between the wings when they are closed, the haptic(s) may become detached from the IOL during advancement through the cartridge tube. Alternatively, the IOL can be loaded on to the cartridge from the landing zone. Place the lens anterior side up on the landing zone. Using rounded blade forceps, push the IOL forward into the hinge portion of the cartridge. Make sure that the edges of the IOL are held below the ledges of the wings. Close the wings and ensure that the leading and trailing haptics are in the correct positions as described above. 7. After closing the wings, hold them together and insert The UNFOLDER Silver Series Cartridge into The UNFOLDER Silver Series Handpiece as shown in Figures 8 and 9, taking care not to damage the cartridge tip. Gently push The UNFOLDER Silver Series Cartridge forward into the slot of The UNFOLDER Silver Series Handpiece until the cartridge stops. Ensure that the cartridge tip is not damaged during the advance of the cartridge into its final position in the handpiece (Figures 8 and 9). Do not advance the rod. Note: The rod and lens should not be advanced until the surgeon is ready to implant the IOL. Allow the assembled system to sit with the handpiece rod retracted as shown in Figure 8 as long as possible, up to 5 minutes. A minimum of 2 minutes is recommended. 8. When the surgeon is ready to implant the IOL, the surgeon should check to ensure the trailing haptic is to the left of the rod and is not caught by the rod. The rod should be pushed forward without rotating the screw mechanism until the screw mechanism bottoms out (stops sliding forward) in the handpiece body. Once the screw is bottomed out, rotate screw mechanism to advance IOL until the leading end of the haptic Note: If the screw mechanism is rotated before it bottoms out in the handpiece body, the screw mechanism can stick. If this happens, rotate the screw mechanism counterclockwise to release it. The surgeon should verify that the leading haptic is pointing forward in the cartridge. The implantation should be performed immediately after the handpiece rod is pushed forward. Note: The lens, cartridge, and sheath should be discarded if the lens is in the advanced position for more than 30 seconds or if the lens has been folded in any position within the cartridge for more than 5 minutes. Note: Never reverse the rod direction until the optic body has been completely released. 9. Insert The UNFOLDER Silver Series Cartridge tube into the incision with the bevel side down. 10. If using The UNFOLDER Silver Series Handpiece; Model PSHST (Fig. 3) Rotate the cartridge to point the bevel and leading haptic to the surgeon s left. Use the screw mechanism to push the lens optic forward until the leading optic edge reaches the bevel of the cartridge. Note: If high resistance is felt, remove the instrument from the eye and discard the lens, cartridge and sheath. When the leading edge of the optic reaches the bevel, begin to rotate the cartridge and handpiece body counterclockwise (while continuing to advance the lens by rotating the screw mechanism) ensuring the leading haptic tip is continuously pointed to the surgeon s left and is not damaged. Note: If the IOL is completely released with the bevel down, the IOL may release upside down. Also, if the leading haptic tip is not pointed to the left after rotation, the IOL may flip after it is released from the tube of the cartridge. Continue advancing the rod until the optic is fully deployed from the tube. If using The UNFOLDER Silver Series Handpiece; Model SILVERT or SILVERZ (Fig. 4) Rotate the cartridge to point the bevel and leading haptic to the surgeon s left. Use the screw mechanism to push the lens optic forward until the leading edge of the optic reaches the tip of the cartridge. Note: If high resistance is felt, remove the instrument from the eye and discard the lens, cartridge and sheath. When the leading edge of the optic reaches the tip of the cartridge, rotate the cartridge and handpiece body counterclockwise (but do not rotate the screw mechanism) while ensuring the leading haptic tip is continuously pointed to the surgeon s left and is not damaged. This twist motion of the cartridge and handpiece body will place the optic into the capsular bag. Although the screw mechanism is not rotated after the leading edge of the optic is at the tip of

4 The cartridge, the screw mechanism will need to move forward to prevent the cartridge from withdrawing from the capsular bag during the counterclockwise rotation of the cartridge and handpiece body. Note: If the IOL is completely released with the bevel down, the IOL may release upside down. Also, if the leading haptic tip is not pointed to the left after rotation, the IOL may flip after it is released from the tube of the cartridge. In addition, if the screw mechanism is rotated after the leading edge of the optic is at the tip of the cartridge, the IOL may release upside down. Note: If the haptic is not pointing to the left once the counterclockwise motion of cartridge and handpiece body has begun, remove hand from screw mechanism and rotate handpiece body with cartridge until haptic is pointed to the left. Once haptic is pointed to the left, hold screw mechanism and continue rotating cartridge and handpiece body counterclockwise (without rotating screw mechanism) until optic body is fully released into capsular bag. Note: As a result of the coarse threads on the SILVERT and SILVERZ handpieces the IOL can retract if screw mechanism is released before IOL reaches the bevel of cartridge. 11. Retract the rod tip just behind the trailing haptic then either 1) withdraw the instrument from the eye and use a second instrument to position the IOL or 2) advance the rod tip, pushing the trailing haptic from the tube and into the capsular bag. Retract the rod until the Silver Series SofTip Sheath is fully enclosed in the cartridge, and then withdraw the instrument from the incision to ensure that the Silver Series SofTip Sheath is fully withdrawn from the eye. Verify that the Silver Series SofTip Sheath remained attached to the rod tip. Do not leave the Silver Series SofTip Sheath in the eye. Precautions 1. Contents are sterile when tray is sealed and undamaged. 2. Overall system performance will be impaired when used in combination with non AMO product. 3. The usage of a viscoelastic is required when loading the IOL into The UNFOLDER Cartridge. Do not use balanced salt solution. 4. Do not use if the instrument has been dropped or inadvertently struck while outside of the shipping case. 5. Do not store the cartridges at temperatures under 41 F or over 86 F. 6. Healon viscoelastics are recommended. Warnings 1. The UNFOLDER Silver Series Implantation System should only be used with the intraocular lenses listed in the Indication for Use section. Do not use this device or any of its components with any other lens. 2. If the cartridge tip is cracked or split prior to implantation, do not use. 3. The lens, cartridge, and sheath should be discarded if the lens is in the advanced position for more than 30 seconds or if the lens has been folded in any position within the cartridge for more than 5 minutes. 4. Never reverse the rod direction until the optic body has been completely released. 5. If an IOL haptic is caught between the wings of the cartridge, the haptic may become detached from the IOL body during implantation. 6. If the IOL is not properly placed in the cartridge, the IOL may flip and be implanted upside down. 7. The UNFOLDER Silver Series Cartridge, Silver Series SofTip Sheath, and Silver Series SofTip Applicator are intended for single use only. Discard after a single use. Do not autoclave or resterilize by any method. 8. Do not advance an IOL through a given cartridge more than once. 9. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design. 10. Never use The UNFOLDER Implantation System without a SofTip Sheath applied to the end of the handpiece rod. 11. Always ensure that the SofTip Sheath is fully engaged on the handpiece rod tip. If it is not, use your sterile-gloved finger to engage the tip firmly against the shoulder of the rod. 12. Avoid methylcellulose viscoelastics. 13. Follow the dwell recommendations for advanced position of the IOL.

5 Warning (Cartridge Only): AMO single use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. The resterilization/reprocessing of AMO single use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection and lack of product sterility. In the U.S.A. telephone: Toll free AMO-4-LIFE

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