INTREPID AutoSert IOL Injector Handpiece Directions for Use

AutoSertTM IOL Injector Handpiece DIRECTIONS FOR USE

Refer to the driving console Operator’s Manual and (addendums) for IOL Injector handpiece compatibility. DESCRIPTION and CHARACTERISTICS of the DEVICE The IOL Injector is an accessory to a cataract surgical system. The IOL Injector itself is a motorized instrument that requires the use of a reusable plunger, an Intra-ocular lens (IOL), an IOL cartridge and viscoelastics so the IOL can be implanted into the eye. The Injector is a reusable device which must be sterilized by steam autoclave. Each package contains one IOL Injector handpiece (Fig. 1), wrench (Fig. 2) and plunger (Fig. 3) that has been attached to the IOL Injector handpiece. The IOL Injector handpiece is intended to implant qualified AcrySof TM intraocular lenses into the eye following cataract removal. The INTREPID™ AutoSert™ IOL Injector handpiece accommodates an ALCON single-use, sterile, cartridge (Fig. 4) Refer to the driving console Operator’s Manual and (addendums) for IOL Injector handpiece compatibility.

Figure 1

Figure 2

Figure 3

INTENDED USE – INDICATIONS for USE The INTREPID AutoSert IOL Injector is intended to be used to implant an intraocular lens following the removal of a cataract. The INTREPID AutoSert IOL Injector handpiece is used in the injection of intraocular lenses after the removal of a cataract. The INTREPID AutoSert IOL Injector handpiece is indicated for use with AcrySof lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof lenses as indicated in the approved labeling of those lenses. CONTRAINDICATIONS

H. Be sure the IOL Injector handpiece connector is dry before connecting it to the console to minimize the risk of patient injury.

No contraindications for the device have been established. CLINICAL BENEFITS

I.

Do not ultrasonically clean the IOL Injector handpiece connector. Ultrasonic cleaning of IOL Injector handpiece connector will cause irreparable damage.

J.

Do not remove the connector from the Driving Console until the IOL Injector handpiece is fully retracted.

K. Extra caution should be used not to bend or impact the plunger when removing the nosecone from the IOL Injector handpiece, and wiping the plunger to remove OVD. Bending or impacting the plunger could affect the delivery performance of the IOL Injector handpiece.

The clinical benefits of the INTREPID AutoSert IOL Injector include the facilitation of implanting an intraocular lens into the eye following the removal of a patient’s cataract. WARNINGS

L. The IOL Injector handpiece is for the implantation of qualified ALCON AcrySof Foldable IOLs. Unqualified lenses shall not be used with the IOL Injector handpiece Delivery System. See table 1 below for the qualified IOL/cartridge/OVD combination for the IOL Injector handpiece Delivery System, or refer to the approved labeling of Alcon IOLs for handpiece compatibility.

1. To prevent infection, destroy the handpiece if used on a patient with prion-related or other infectious disease. 2. Maintenance/Limitations on Reprocessing: Before each use, the IOL Injector handpiece and power cord should be inspected for damage (e.g. nicks, crimps, dents, exposed wire). If the IOL Injector handpiece is damaged, immediately remove it from service. Use of a damaged IOL Injector handpiece may result in serious permanent patient injury.

M. The IOL Injector handpiece is non-sterile and must be cleaned and sterilized prior to first use, and after each use.

3. Never immerse the IOL Injector handpiece in liquid after autoclaving; allow it to air cool for at least 15 minutes. Quenching could result in a potentially hazardous condition for the patient, such as inflammation.

TABLE 1 QUALIFIED IOL/CARTRIDGE/OVD COMBINATION Cartridge (Product REF)

4. Do not detach the nosecone once the plunger and cartridge are attached to the IOL Injector handpiece. This could result in a potentially hazardous condition for the patient, such as ocular tissue damage, inflammation, or infection.

OVD (Product REF)

5. Do not immerse the IOL Injector handpiece in any fluid when the IOL Injector handpiece is not retracted. This could result in a potentially hazardous condition for the patient, such as inflammation or infection. 6. The cartridge/IOL combination listed in Table 1, along with Alcon settings, has been validated per section 5 of ISO 11979-3:2006 and at an ambient temperature of 18° C using the driving console setting (1.7 mm/sec, 3 seconds, and 3.0 mm/sec for initial velocity, pause and final velocity respectively). Using a higher velocity and shorter pause at lower temperatures, especially with high-diopter lenses, could induce damage to IOL and/or IOL cartridge, affecting successful IOL implantation and cause ocular tissue damage. See Lens Delivery section, step 4 and 6, of this document on resolving a trailing haptic situation. 7. Fully retract the plunger before detaching the nosecone from the INTREPID AutoSert IOL Injector. Otherwise this could expose the non-sterile portion of the shaft and result in a potentially hazardous condition for the patient, such as ocular tissue damage, inflammation or infection.

MONARCH™ III D (8065977763)

8. For the intended IOL to be implanted, the proper cartridge profile MUST BE SELECTED from the driving console AND the proper plunger MUST BE ATTACHED TO THE INTREPID AutoSert IOL INJECTOR. Failure to do so can result in a potentially hazardous condition for the patient, such as ocular tissue damage.

VISCOAT™ (8065183905) (8065183975)

9. The metal reusable plunger must be sterilized after each use. The reusable plunger is to be installed onto the handpiece or into the wrench prior to sterilization. Failure to do so can result in a potentially hazardous condition for the patient, such as ocular tissue damage. PRECAUTIONS A. Use of this product may require surgical setting adjustments. Ensure that appropriate system settings are used with the INTREPID AutoSert IOL Injector handpiece. Prior to initial use, contact your Alcon Sales Representative for in service information. (Within the U.S., call 800-TO-ALCON, or 817-293-0450. Outside of the U.S., contact your local Alcon Sales Representative.) B. As part of a properly maintained surgical environment, it is recommended that a backup IOL injector be made available in the event the INTREPID AutoSert IOL Injector handpiece does not perform as expected. C. Not all cartridge/lenses/OVD (Ophthalmic Viscosurgical Device) combinations are currently approved in all countries. For information on the latest approved combinations in your region, contact your local Alcon surgical sales representative. D. Do not use if the IOL Injector handpiece is received in a defective condition. In these cases, please contact: By Phone:

By Website:

In USA: (800) 757-9780

http://www.alcon.com/contact-us/

Diopter Range

SN60WF

+6.0 to +27.0

SN6AD1

+6.0 to +25.5

SND1T2** SND1T3** SND1T4** SND1T5** SND1T6**

+6.0 to +25.0

SN6AT2** SN6AT3 SN6AT4 SN6AT5 SN6AT6 SN6AT7 SN6AT8 SN6AT9

+6.0 to +23.0

SV25T0**

+6.0 to +27.0

SV25T2** SV25T3** SV25T4** SV25T5** SV25T6**

+6.0 to +25.0

PACKAGING The IOL Injector handpiece is packaged in a single-wall corrugated fiberboard tuck-folded box with open cell polyether foam inserts. The handpiece is provided in a non-sterile condition and must be cleaned and sterilized via autoclave prior to use. DIRECTIONS FOR USE Keep this Directions for Use document for reference when using this handpiece. This Directions for Use document is intended to supplement the driving console Operator’s Manual. The manual includes in-depth information for familiarizing the operating room staff with the controls and functions of the instrument. The cleaning and sterilization instructions in this Directions for Use document provide a validated method for effectively cleaning and sterilizing the INTREPID AutoSert IOL Injector handpiece per ISO 17664. Due to the potential for Toxic Anterior Segment Syndrome (TASS), Alcon does not recommend the use of enzymatic cleaners, detergents or disinfectant solutions. If however, local jurisdictions mandate their use relative to ophthalmic instruments, the materials of construction are compatible with both, up to a pH of 11.3, when the enzymatic chemicals, detergents or disinfectant solutions are completely rinsed/ neutralized immediately after cleaning/processing per the surgical facility’s procedure. Alcon has determined that the use of cleaners containing amines can lead to premature degradation and weakening of the handpiece cable jackets; therefore, Alcon advises against using these cleaners.

Each IOL Injector handpiece is identified by a serial number which provides traceability and should be given to your local Alcon representative when discussing the IOL Injector handpiece. E. Maintenance/Limitations on Reprocessing: Each time the IOL Injector handpiece is connected to the driving console, it performs a calibration cycle. If the IOL Injector handpiece performs improperly and fails the calibration cycle, remove it from the driving console and return it to Alcon for evaluation. F. Use care in handling the IOL Injector handpiece, particularly in cleaning. Always clean the IOL Injector handpiece over a surface cushioned with a pad or rubber mat to prevent contamination.

210-3384-001 REV B

Qualified Lens Models

**-NOT CLEARED FOR USE IN USA

In EU/International: Contact your local Alcon Representative

300051146 REV. A

Figure 4

G. The IOL Injector handpiece is to be used with only the approved ALCON surgical systems. See the particular Operator’s Manual of the surgical system for a list of the appropriate IOL Injector handpiece for that system.

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1. Set up - Cartridge Installation:

Step 2 Re-attach the nosecone onto the IOL Injector handpiece by first aligning both index lines shown in Figure 11, then slide the nosecone onto the IOL Injector handpiece and rotate the nosecone clock-wise until secured. Step 3 Submerge the IOL Injector handpiece, wrench and nosecone excluding the connector, in a container of room temperature sterile deionized water for a minimum of 5 minutes. Do not allow viscoelastics or debris from the surgery to dry on the instrument prior to cleaning. Step 4 Remove the nosecone and flush the length of the plunger, shown in Figure 8, and nosecone with room temperature sterile deionized water for a minimum of 5 seconds. Step 5 Using a soft bristle brush, brush the gap between the plunger/IOL Injector handpiece (Fig. 9) and nosecone lumen (Fig. 10) under room temperature sterile deionized water for a minimum of 5 seconds.

Step 1 Refer to the cartridge DFU on loading the IOL into the cartridge. See Table 1 of this DFU for the approved IOL/cartridge/OVD combination. Step 2 Insert the cartridge into the IOL Injector handpiece (1st step) and fully slide the cartridge forward into the IOL Injector handpiece slot (2nd step) as shown in Figures 5a and 5b. See Console Operator’s Manual on the PRELOAD LENS function. 1st Step

Figure 5a

Figure 5b

2nd Step

Gap

Nosecone Lumen

2. Lens Delivery Step 1 During the pre-load function, the plunger should make initial contact with the cartridge at the ramp. In the event the plunger does not contact the cartridge at the ramp, do not use the IOL Injector handpiece and contact Alcon. Step 2 Verify the lens moves forward at the same rate as the plunger. Step 3 As the lens moves through the cartridge, verify that the plunger tip is behind the optic and the leading haptic is looped in front of the optic. The leading haptic may become looped back between the folded halves of the optic, which is acceptable. Step 4 Visually inspect the lens to ensure proper interface between the lens and plunger. If any sign of over-ride (Figure 6a) or under-ride (Figure 6b) occurs, retract the plunger and replace it per section 11 (Plunger Installation section of this document). In the event a trailing haptic is detected (Figure 6c) at the pre-load lens position, fully retract the plunger and use another AcrySof TM IOL and Monarch cartridge. Figure 6a

Figure 9

Step 6 Re-attach the nosecone onto the IOL Injector handpiece by first aligning the index lines (Figure 11) then insert the nosecone onto the IOL Injector handpiece then lock the nosecone by rotating the nosecone clockwise.

Figure 11

Plunger Over-ride (viewed from bottom of cartridge and cross-sectional view) IOL

Figure 10

Step 7 Ultrasonically clean the IOL Injector handpiece (excluding the connector) with the nosecone/plunger attached (Figure 12a) and wrench separated from the IOL Injector handpiece (Figure 12b) in room temperature sterile deionized water for a minimum of 5 minutes.

Cartridge

Plunger Nosecone Figure 6b

Figure 12a

Plunger Under-ride (viewed from bottom of cartridge and cross-sectional view) IOL

Figure 12b

Cartridge

Step 8 Thoroughly rinse the nosecone lumen with room temperature sterile deionized water for a minimum of 15 seconds. Step 9 Shake off excess fluids and dry the surfaces of IOL Injector handpiece and wrench with a soft, clean, lint free nonabrasive cloth. Step 10 Visually inspect to ensure the IOL Injector handpiece is clean, dry, and undamaged. Repeat the process as needed. 5. Manual Cleaning Procedure

Plunger Nosecone Figure 6c

Trailing haptic (viewed from top)

Refer to Point of Use Cleaning Procedure. No additional cleaning necessary. Proceed directly to Automated Cleaning Procedure (section 6 below) or Inspection/Storage Prior to Sterilization (section 7 below) per facility requirements. 6. Automated Cleaning Procedure Ensure first that the Point of Use Cleaning Procedure is completed and then perform the following steps to process the handpiece. NOTE: a. Due to the potential for accumulation of particulate and bioburden residues in the washer-disinfector water reservoirs, it is the surgical facility’s responsibility to properly maintain the equipment and their associated filters to ensure the introduction of contaminate-free solutions into the IOL Injector handpiece. b. The temperature and cycle parameters below will not cause damage to the product. c. Do not wash the IOL Injector handpiece with non-ophthalmic instruments. Step 1 Clean the IOL Injector handpiece immediately after each surgical procedure per the Point of Use cleaning procedure above before using an automated washer-disinfector. Step 2 Prepare the washer-disinfector with multi-purpose injector per Operator’s Manual. Use an ISO 15883 compliant washer-disinfector. The use of a typical automated washer-disinfector and wire basket is depicted below. NOTE: Use de-ionized water only Required material: • Detergent with pH range of 8.5 to 9.5. • Organic acid neutralizer with pH range of 3.0 to 2.6. • Adaptors and silicone tubing, e.g. Customized Auto Wash Kit: Alcon REF 8065750456. Step 3 Set detergent and neutralizer dispensers as recommended by detergent and washer-disinfector manufacturer. Step 4 Program washer-disinfector to have the following automated cycle: • Main wash at a minimum of 55° C for at least 10 minutes (dispense detergent as recommended by detergent and washer-disinfector manufacturer). • Neutralizer for a minimum of 1.5 minutes (dispense neutralizer as recommended by detergent and washer-disinfector manufacturer). • Rinse for a minimum of 5 minutes at 22-27° C then drain. • Repeat rinse a minimum of for 5 minutes at 22-27° C then drain. • Final Rinse at a minimum of 70° C for at least 1.5 minutes then drain***. • Dry at a minimum of 100° C for at least 5 minutes. ***Note: Additional rinsing steps will not alter the effectiveness of the validated cycle. Rinsing duration or temperature may be increased up to 95° C if desired to achieve thermal disinfection in accordance with local facility procedures.

Step 5 Insert the tip of the cartridge through the incision. Position the tip at the anterior capsule opening. If the leading haptic is looped in front of the optic, rotate the cartridge to be slightly bevel left to facilitate placement of the leading haptic into its normal orientation in the bag. Step 6 Advance the lens only until the optic exits the nozzle, rotating the cartridge towards bevel right as needed to place the lens anterior side up. During IOL implantation if the trailing haptic does not exit the cartridge when the plunger is fully extended, retract the plunger to the pre-loaded position then fully extend the plunger to complete the IOL implantation. Step 7 Withdraw the cartridge nozzle. Step 8 Place and center the lens using a suitable positioning instrument. 3. Preparation For Point Of Use Cleaning (Immediately After Use) Step 1 After the plunger has been fully retracted, remove the cartridge from the IOL Injector handpiece. Discard the cartridge. Step 2 As shown in Figure 7, detach the nosecone from the IOL Injector handpiece by rotating the nosecone counter clock-wise first, then carefully slide it away from the IOL Injector handpiece so it does not deflect the plunger Nosecone

Figure 7

4. Point Of Use Cleaning Procedure (Immediately After Use) Thoroughly clean the IOL Injector handpiece before initial use and IMMEDIATELY after each subsequent use. Do not store or allow the IOL Injector handpiece to dry after use until thoroughly cleaned. Perform the following steps to manually clean the IOL Injector handpiece. Step 1 Wipe any residue from the IOL Injector handpiece body, Nosecone, and the exposed plunger (Fig. 8) with a soft, lint-free non-abrasive cloth. Plunger Figure 8

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Table 3 - STERILIZATION TEMPERATURE AND TIME SETTINGS (USA) CONFIGURATION

MINIMUM TEMPERATURE

MINIMUM EXPOSURE TIME IN MINUTES

Gravity Displacement

Wrapped

132° C (270° F)

15

15

Gravity Displacement

Unwrapped6

132° C (270° F)

10

N/A

Pre-vacuum

Wrapped

135° C (275° F)

3

16

Pre-vacuum

Unwrapped6

132° C (270° F)

4

N/A

STERILIZER TYPE

Step 5 Using the Auto Wash Kit, insert one end of the ASSY, Adapter AquaLase™ Custom tubing onto the exposed portion of the plunger. Note: Do not insert the tubing into the nosecone lumen.

Step 6 Using the Auto Wash Kit, secure the tubing to the nosecone using the small gauge wire as shown. Note: The tubing is not to be occluded by the wire.

MINIMUM DRYING TIME IN MINUTES

Note: Immediate use sterilization cycles intended to support urgent clinical needs only. Please refer to AAMI ST79 for additional guidance.

6

9. Sterilization Wrap: Sterilization wrap used must provide sterile barrier as per ISO 11607-1 and be secured as needed to ensure sterility is maintained when moving product about facility. 10. Cleaning After Last Surgery

Step 7 Place the AutoSert™ IOL Injector Handpiece, horizontally, into the wire mesh basket, as shown. Remove fitting from ASSY, Adapter AquaLase™ Custom tubing and connect the tubing to the nozzle as shown.

At the end of the last surgery of the day, while the IOL Injector is connected to the console, fully extend the IOL Injector handpiece shaft (shown in Fig. 13). Remove the nosecone and wipe the exterior IOL Injector handpiece shaft enclosed by the dotted line with a soft, clean, lint free non-abrasive cloth. After wiping, reinstall the nosecone then fully retract the IOL Injector handpiece.

Step 8 Plug off any unused nozzle with silicone tubing.

Figure 13

Pictured: Miele* Labwasher, Model G7735 with Injector Model # 0-177. Shaft

Step 9 Start the wash program. When the wash program is completed, visually inspect to ensure the IOL Injector handpiece is clean, dry, and undamaged. Repeat the process as needed. Then replace the processed IOL Injector handpiece and cable in an autoclavable tray to prevent damage to connector and IOL Injector handpiece during storage and autoclaving. Step 10 The IOL Injector handpiece shall be immediately sterilized after auto wash cycle is completed. 7. Inspection/Storage Prior to Sterilization

11. Plunger Removal/Installation: In the event the plunger is dislodged from the IOL Injector handpiece, perform the following steps to attach the plunger into the IOL Injector handpiece. Step 1 To remove the plunger, fully extend the Injector as shown in Figure 13a, then detach the plunger from the shaft by grasping the plunger, where indicated, and pull it away from the Injector. Fully retract the Injector.

Visually inspect to ensure device is clean, dry, and undamaged. Place the processed handpiece and cable in an autoclavable tray to prevent damage to connector and handpiece during storage and autoclaving or wrap to prevent damage in preparation for autoclaving. Storage conditions (temperature, humidity, altitude) are not restricted. 8. Sterilization

Then pull away from shaft to detach the plunger

After cleaning procedures are completed, sterilize the INTREPID™ AutoSert IOL Injector handpiece as soon as practical in one of the configurations below using a steam sterilization cycle. Configuration 1

Figure 13a

Configuration 2

• Plunger and nosecone attached to the IOL Injector • Wrench detached from the IOL Injector

• Nosecone attached to the IOL Injector • Wrench detached from the IOL Injector with the plunger inserted into wrench (Figure 14b)

Grasp the plunger here for removal Step 2 As shown in Figures 14a and 14b, insert the plunger into the wrench.

The sterilization installation instruction provided in Table 2 below have been validated by Alcon Laboratories, Inc. as being CAPABLE of sterilizing the IOL Injector handpiece for re-use. The sterilization instructions in Table 3 are intended for USA users and have been validated by Alcon Laboratories, Inc. in accordance with FDA guidance as being capable of sterilizing the handpiece for reuse. It remains the responsibility of the processor to ensure that the processing as actually performed using equipment, materials and personnel in the facility achieve the desired result. This requires verification and routine monitoring of the process. Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences. Please refer to ISO 17665-1 and nationally recognized standards such as AAMI Standards, or to your facility’s standard procedures. Note: Due to the potential for the accumulation of particulate and bio-burden residues in their sterilizer water reservoirs, it is the surgical facility’s responsibility to properly maintain the equipment and their associated filters to ensure the introduction of steam into the IOL Injector handpiece is contaminant-free at the levels acceptable per the surgical facility’s requirements. After sterilization, allow the components to cool and re-tighten the nosecone to the IOL Injector handpiece.

Figure 14a

Step 3 As shown in Figure 15a to 15c, install the wrench/plunger into the IOL Injector handpiece nosecone. See driving console Operator’s Manual on the LOAD PLUNGER function.

Table 2 - STERILIZATION TEMPERATURE AND TIME SETTINGS1 CONFIGURATION MINIMUM MINIMUM PULSES EXPOSURE TIME (ISO 11607-1 TEMPERATURE3 2 IN MINUTES compliant wrap ) Gravity N/A Wrapped 132° C (270° F) 15 Displacement Gravity N/A Unwrapped5 132° C (270° F) 10 Displacement Pulsing 4 Unwrapped5 132° C (270° F) 4 Pre-vacuum STERILIZER TYPE

Pulsing Pre-vacuum Pulsing Pre-vacuum

4

Wrapped

135° C (275° F)

3

4

Wrapped

134° C (273° F)4

3

Figure 14b

Figure 15a

Figure 15b

Figure 15c (viewed from bottom)

Step 4 Observe the plunger during the installation. A gap should not exist between shaft and plunger after installation (Figure 16a). If a gap exists between the plunger and shaft (Figure 16b), remove the plunger from the shaft and repeat plunger installation step and apply adequate force, using fingers, shown in Figure 16c during the load plunger process. NOT OK

OK

Notes: 1 This product has been validated to perform reliably after steam sterilization at 134° C (273° F) for 18 minutes (pre-vacuum, wrapped). 2 “Wrapped” refers to use of central processing sterilization wrap material, compliant to ISO 11607-1 requirements, and appropriately secured to ensure sterility is maintained. Single or double wrapping techniques are both acceptable; each technique does not impact the effectiveness of the sterilization cycle. 3 Facilities targeting specific minimum lumen temperatures at sterilization inception may find temperature will rise more rapidly by vertically orienting handpieces. 4 Validated at 134° C to accommodate European Community requirements for a 134° C cycle of 3 minute duration. 5 Intended to support urgent clinical needs only. Please refer to regional standards or local facility procedures for additional guidance.

Figure 16a

Figure 16b Apply force Here Figure 16c

Step 5 After the Plunger is installed on to the IOL Injector handpiece, remove the wrench from the IOL Injector handpiece.

300051146 REV. A 210-3384-001 REV B

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DEFINITIONS

12. Plunger Replacement During Surgery:

Definitions for symbols that appear on product labels:

Perform the following step to replace the plunger during surgery. Step 1 If necessary, fully retract the Injector and remove the cartridge. Step 2 With the Injector fully extended and nosecone attached, detach the plunger from the shaft by grasping any portion of the plunger extending beyond the nosecone then pull it away from the Injector. Fully retract the Injector. Step 3 Load the new plunger per instruction in step two to five in section 11 of this document. 13. Console Setup: After transport to the driving console for the next use, refer to the driving console Operator’s Manual for proper surgical setup. 14. Limitations For Reprocessing: Reuse is limited by physical damage (see warning #2) and failure of pre-surgical calibration cycle (see precaution E). Due to chemicals used during reprocessing, the handpiece connector may experience discoloration. When the handpiece is used properly per this Directions for Use, 400 re-uses have been verified.

CONSULT INSTRUCTIONS FOR USE OR CONSULT ELECTRONIC INSTRUCTIONS FOR USE

DO NOT USE IF PACKAGE IS DAMAGED AND CONSULT INSTRUCTIONS FOR USE

CATALOG NUMBER

MANUFACTURER COUNTRY OF MANUFACTURE: CC

15. Storage: Storage conditions (temperature, humidity, altitude) are not restricted. See warning #2 for indicators of device end of life.

MEDICAL DEVICE

REFERENCES Standards: ISO 17664, ISO 17665-1, ISO 11607-1, ISO 15883-1/-2, ISO 11979-3, AAMI ST79 Other Guidance: Robert Koch Institute (RKI) Guidelines, DGHK/DGSV/AKI Guidelines (current Zentral Steril Supplement) SERIOUS INCIDENT REPORTING

SERIAL NUMBER

CC

YYYY-MM-DD

DATE OF MANUFACTURE : YYYY-MM-DD DOES NOT CONTAIN LATEX OR DRY NATURAL RUBBER

AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

Any serious incident related to the use of this medical device should be reported to Alcon Laboratories, Inc.:

CAUTION: U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

By Phone: In USA: (800) 757-9780 In EU / International - Contact the local country office or your Alcon distributor. By website: http://www.alcon.com/contact-us/ By email:

[email protected] www.ifu.alcon.com

These serious incidents should also be reported to the competent authority for medical devices of your State.

Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 USA Made in USA with Global Materials

*Registered trademark of Miele & CIE KG © 2021, 2022 Alcon Inc.

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Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 USA Made in USA with Global Materials 300051146 REV. A ISSUED: 12-MAY-2022