CLAREON MONARCH IV IOL Delivery System Instructions for Use

CONTRAINDICATIONS There are no known contraindications to the use of the CLAREON™ MONARCH™ IV IOL Delivery System when used as recommended. WARNINGS Complications with the CLAREON™ MONARCH™ IV IOL Delivery System used in conjunction with cataract surgery and IOL implantation include the following: physical injury, postoperative inflammation, prion infection, toxic reactions (i.e., toxic anterior segment syndrome), irritation, corneal endothelial cell damage, infection (e.g endophthalmitis, systemic infection), retinal detachment, corneal edema, pigment dispersion, tissue damage (e.g., capsular tissue damage, iris damage and zonular damage), decreased or blurred vision, unexpected postoperative refraction, visual disturbance, IOL decentration, tilt or dislocation and elevated IOP. HANDPIECE PRECAUTIONS 1. A high level of surgical skill is required for intraocular lens implantation. The surgeon should have observed and/or assisted in numerous implantations and successfully completed one or more courses on intraocular lens implantation before attempting to implant intraocular lenses. 2. Read all instructions prior to use. 3. The handpiece is non-sterile and must be cleaned and sterilized prior to each use (refer to Handpiece Preparation section of this Instructions for Use). Failure to properly sterilize handpiece could result in serious infection (e.g., endophthalmitis and systemic infection). 4. Use of hydrogen peroxide may discolor titanium instruments. 5. Mixing titanium and stainless steel instruments during sterilization may result in discoloration of the instruments. 6. If a patient with a prion-related disease undergoes a procedure which, in the medical opinion of the physician, poses a high risk of instrument contamination, the instrument should be destroyed or processed according to local requirements. ORDERING INFORMATION Contact Alcon Sales Representative with the correct Product Order Number. SERIOUS INCIDENT REPORTING Any serious incident that may reasonably be regarded as device-related should be reported to Alcon Laboratories, Inc.: By Phone: International - Contact the local country office. By Email: In Europe: [email protected] Website: http://www.alcon.com/contact-us/ Each handpiece and cartridge is identified by a lot number which provides traceability, and this information should be given to Alcon. NOTE: In Europe, serious incidents must also be reported to the competent authority for medical devices of the appropriate State. PERFORMANCE CHARACTERISTICS An evaluation of postmarket surveillance, clinical investigations, and clinical literature data support that the MONARCH™ II/III IOL Delivery System has an acceptable safety and performance profile when used to implant qualified Alcon foldable IOLs. Adverse events rates associated with using the MONARCH™ II/III IOL Delivery System are low while clinical outcomes are favorable. Clinical outcomes were consistent with the intended use of the MONARCH™ II/III IOL Delivery System. Based on the similarity of CLAREON™ MONARCH IV™ IOL Delivery System to the MONARCH II/III IOL Delivery System, the clinical performance of CLAREON™ MONARCH™ IV IOL Delivery System is expected to be comparable. CLINICAL FEATURES of the CLAREON™ MONARCH™ IV IOL Delivery System The CLAREON™ MONARCH™ IV IOL Delivery System (handpiece and cartridge) is qualified with Alcon foldable IOLs and has the following features: • The CLAREON™ MONARCH™ IV IOL Delivery System allows for the implantation of qualified Alcon foldable IOLs into the eye following removal of the crystalline lens. • The CLAREON™ MONARCH™ IV IOL Delivery System provides a controlled means to reliably place the qualified Alcon foldable IOL into the capsular bag. INSTRUCTIONS FOR USE Handpiece Preparation Step 1.

Thoroughly clean and sterilize the handpiece prior to the first use.

 NOTE: The handpiece must also be cleaned and then sterilized after each subsequent use. The handpiece must be sterilized in accordance with guidelines provided (refer to Handpiece Cleaning and Handpiece Sterilization). Step 2. Inspect the handpiece prior to each use to ensure that it is not damaged. 2.1. Push the knob forward until the threads contact the barrel. 2.2. Turn the knob clockwise to advance the plunger. 2.3. Ensure the plunger moves smoothly through the entire delivery process until the knob touches the housing.  IMPORTANT: The use-life of an un-damaged CLAREON™ MONARCH™ IV handpiece, when used per the IFU, is indefinite. In the event the handpiece (particularly the plunger tip) appears damaged, bent, or incapable of proper use, DO NOT use the handpiece, and contact Alcon. Step 3.

Retract the plunger of the handpiece completely for cartridge loading.

 NOTE: For instructions on how to load the lens into the MONARCH™ cartridge, please refer to the Instructions for Use for the MONARCH™ cartridge. Cartridge Loading As shown in Figures 3 and 4, Step 1.

S  lide the cartridge backwards underneath the hood into the cartridge slot of the handpiece.

Step 2. Slide the cartridge fully forward into the handpiece slot until it is secured firmly into position.

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Figure 4: Insertion of loaded MONARCH™ cartridge into handpiece

Figure 3: MONARCH™ cartridge with IOL

IOL folding and advancement Step 1.

Advance the plunger in one slow motion to advance and fold the optic.

 IMPORTANT: 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 handpiece and contact Alcon. Step 2. Verify that the plunger tip is properly engaging the lens optic (Figure 5), and the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens. This configuration shown has both haptics tucked.

Note: It is not recommended to proceed to implantation with a straight trailing haptic.

Figure 5: Plunger tip contacting the folded IOL inside the MONARCH™ Cartridge

Figure 6: Straight trailing haptic configuration

Step 3. When the threads on the knob make contact with the barrel as shown in Figure 7, turn the knob clockwise approximately ½ turn to engage the threads and then STOP. The IOL will now be in the dwell position as shown in Figure 8.  DO NOT advance the IOL beyond the dwell position until the time of IOL implantation.

NOTE: Refer to IOL DFU for dwell time limitations.

Figure 8: IOL in dwell position

Figure 7: Turning knob of handpiece to engage the threads Step 4.

Inspect to ensure the plunger is behind the optic as shown in Figure 8.

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IOL Implantation Step 1. Insert the tip of the cartridge through the incision. Position the tip at the anterior capsule opening. If the leading haptic is looped or straight in front of the optic, rotate the cartridge clockwise as needed to be bevel left to facilitate placement of the leading haptic into its normal orientation in the bag. Step 2.

Slowly advance the lens until the optic is exiting the nozzle. Rotate the cartridge counter-clockwise towards bevel right as needed to place the lens anterior side up.

Step 3. Continue to advance the plunger as needed to deliver the lens fully. Then, withdraw the cartridge nozzle. Step 4.

Place and center the lens using a suitable positioning instrument.

Step 5.

 o special disposal of the MONARCH™ cartridge is required after normal use. Safely discard the MONARCH™ cartridge in accordance with local laws N and regulations.

HANDPIECE CLEANING AND STERILIZATION All provided reprocessing instructions have been validated by Alcon and provide methods for effectively cleaning and sterilizing the CLAREON™ MONARCH™ IV handpiece per ISO 17664. Data are available to support 1000 simulated use and reprocessing cycles. Due to the potential for Toxic Anterior Segment Syndrome (TASS), Alcon does not recommend the use of enzymatic cleaners and detergents. 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. Both a manual cleaning process and a cleaning process using an automated washer are presented. Manual Cleaning Procedure The following cleaning instructions provide a method for effectively cleaning the handpiece. ! IMPORTANT • Thoroughly clean the handpiece immediately before first use and after each subsequent use. • Manual cleaning should be performed immediately after each surgical procedure. • Although not recommended, the materials of construction of the handpiece are compatible with enzymatic cleaners and detergents. However, improper rinsing and removal of enzymatics and detergents from Ophthalmic Surgical Instrumentation have been linked to Toxic Anterior Segment Syndrome. Step 1. Wipe the plunger with a lint free cloth immediately after each use. Advance the plunger forward for access to plunger tip. Step 2.

Soak the handpiece for at least 5 minutes in water.

 IMPORTANT: DO NOT allow OVD or debris from surgery to dry on the instrumentation prior to cleaning. Step 3.

Flush the handpiece for at least 5 seconds using tap water.

Step 4. Brush the handpiece for at least 5 seconds using a small, soft brush to remove OVD and cellular debris.  NOTE: The use of hydrogen peroxide may cause discoloration of the handpiece. Step 5. Ultrasonically clean for at least 5 minutes in water. Retract the plunger completely to protect the plunger tip during the cleaning. Step 6. Visually inspect the handpiece to ensure: • No visible soil remains; repeat cleaning if necessary. • It is not damaged. 6.1. Advance the knob forward until the threads contact the barrel. 6.2. Turn the knob clockwise to ensure that the plunger can be advanced smoothly and completely. 6.3. In the event the handpiece appears damaged or incapable of proper use, contact Alcon. Step 7. Perform a final, thorough rinsing of the handpiece with distilled, sterile water for at least 15 seconds. 7.1. Hold the handpiece vertically to allow water to drain. 7.2. Dry with a sterile, lint-free instrument wipe. Step 8.

Store instrument in a protective tray.

Automated Washer Procedure In the event use of an automated process is required, perform all of the following steps to process the handpiece. ! IMPORTANT • Before using an automated washer, manually clean the handpiece immediately after each surgical procedure per the manual cleaning procedure above. • Due to the potential for the accumulation of particulate and bio-burden residues in the washer water reservoirs, it is the surgical facility’s responsibility to properly maintain the equipment and their associated filters to ensure the introduction of contaminant-free solutions onto the handpiece. • This automated washing procedure provides a method per ISO 17664 (1) for effectively processing of the handpiece(s). • The temperatures and cycle parameters below will not cause damage to the product. • DO NOT wash the handpiece with non-ophthalmic instruments. Step 1. Prepare the washer per Operator’s Manual. The circulation rate of the automated washer should be at least 106 gallons (401 liters) of water per minute. NOTE: Use de-ionized water only. Required materials: • Detergent with pH range of 8.5 up to 9.5 • Organic acid neutralizer with pH range of 3.0-2.6. Step 2. Set detergent and neutralizer dispensers as recommended by detergent and washer manufacturer.

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Step 3. Program washer to have the following automated cycle: • Main wash at 55° C for 10 minutes (dispense detergent as recommended by detergent and washer manufacturer) •  Neutralize for a minimum of 1.5 minutes (dispense neutralizer as recommended by detergent and washer manufacturer) • Rinse for 5 minutes at 22° C to 27° C then drain • Repeat rinse for 5 minutes at 22° C to 27° C then drain • Final Rinse at 70° C for 1.5 minutes then drain • Dry at 100° C for 5 minutes  NOTE: Additional rinsing steps will not alter the effectiveness of the validated cycle. Step 4.

Start the wash program.

Step 5.

When the wash program is completed, replace the cleaned handpiece in the sterilization tray to prevent damage to the handpiece during storage and autoclaving.

Handpiece Sterilization ! IMPORTANT The handpiece must be cleaned and sterilized prior to the first use and after each subsequent use. Place the handpiece in a sterilization tray as shown in Figure 9 ensuring that the plunger is retracted and the tip is protected. Sterilize the handpiece using a steam sterilization cycle. The sterilization instructions provided in Table 2 below have been validated by Alcon as being CAPABLE of sterilizing the CLAREON™ MONARCH™ IV Handpieces for re-use. 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 nationally recognized standards, such as AAMI Standards (2, 3, 4) or to your facility’s standard procedures.

Figure 9: Placement of CLAREON™ MONARCH™ IV handpiece in sterilization tray Note: Due to the potential for the accumulation of particulate and bio-burden residues in the sterilizer water reservoirs, it is the surgical facility’s responsibility to properly maintain the equipment and their associated filters to ensure the introduction of contaminant-free steam onto the handpiece. Table 2: Sterilization Temperatures and Time Settings CYCLE TYPE

SAMPLE CONFIGURATION

TEMPERATURE

MINIMUM EXPOSURE TIME (MINUTES)

MINIMUM DRYING TIME (MINUTES)

Gravity

Wrapped

132° C (270° F)

15.0

45.0

Gravity

Unwrapped

132° C (270° F)

10.0

---

Pulsing Prevacuum

Unwrapped

132° C (270° F)

4.0

---

Pulsing Prevacuum

Wrapped

132° C (270° F)

4.0

30.0

Pulsing Prevacuum

Wrapped

135° C (275° F)

3.0

16.0

Wrapped

134° C - 137° C (273° F - 279° F)

3.0*

30.0

Pulsing Prevacuum

*Several European national health authorities recommend a minimal sterilization time of 18 minutes at 134°C (273°F). References: 1. ISO 17664: Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices. 2. AAMI TIR12: Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers. 3. AAMI TIR30: A compendium of processes, materials, test methods and acceptance criteria for cleaning reusable medical devices. 4. ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

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STAND ALONE SYMBOLS FROM ISO 7000 USED ON LABELING (ISO 7000/IEC 60417* Title: Graphical Symbols for Use on Equipment) Symbol

Reference Number from ISO 7000 / IEC 60417*

Symbol Title / Explanatory Text

2492

Batch code

2493

Catalogue number

0434A

Caution

3082

Manufacturer

1641

Consult instructions for use or consult electronic instructions for use

2497

Date of Manufacture

6049*

Country of manufacture

*This symbol is from IEC 60417. ABBREVIATIONS or OTHER SYMBOLS USED ON LABELING Abbreviation or Symbol

Explanatory Text Medical device

IOL

Intraocular lens

Cartridge

Handpiece

OVD

Ophthalmic viscosurgical device Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician

Authorized Representative in the European Union

Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 USA

Alcon Laboratories Belgium Lichterveld 3 2870 Puurs-Sint-Amands Belgium

© 2021 Alcon Inc.

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