MONARCH Loading Forceps Instructions

CONTENTS ENGLISH CZECH DANISH DUTCH ESTONIAN FRENCH GERMAN GREEK HUNGARIAN ITALIAN LATVIAN

INSTRUCTIONS FOR USE NÁVOD K POUŽITÍ BRUGSANVISNING GEBRUIKSAANWIJZING KASUTUSJUHISED INSTRUCTIONS D’UTILISATION GEBRAUCHSANWEISUNG ΟΔΗΓΊΕΣ ΧΡΉΣΗΣ HASZNÁLATI ÚTMUTATÓ ISTRUZIONI PER L’USO LIETOŠANAS INSTRUKCIJA

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LITHUANIAN NORWEGIAN POLISH PORTUGUESE ROMANIAN RUSSIAN SLOVAK SPANISH SWEDISH TURKISH UKRAINIAN

NAUDOJIMO INSTRUKCIJA BRUKSANVISNING INSTRUKCJE UŻYCIA INSTRUÇÕES DE UTILIZAÇÃO INSTRUCŢIUNI DE UTILIZARE ИНСТРУКЦИИ ПО ПРИМЕНЕНИЮ NÁVOD NA POUŽITIE INSTRUCCIONES DE USO BRUKSANVISNING KULLANMA KILAVUZU ІНСТРУКЦІЇ З ВИКОРИСТАННЯ

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1. Product description and intended use The GRIESHABER™ MONARCH™ Loading Forceps are handheld instruments intended to be used in anterior segment ophthalmic surgery for handling of an Alcon qualified foldable Intraocular Lens (IOL) from its packaging into an Alcon MONARCH™ Cartridge. The GRIESHABER MONARCH Loading Forceps are used during preparation of the IOL prior to its implantation. The specific design of the forceps allows the user to grasp the IOL, take it out of its packaging and load it correctly into an Alcon MONARCH Cartridge. The instruments are sold nonsterile and are suitable for reprocessing and reuse. 2. Indications for use and intended user The instruments are used in anterior segment ophthalmic surgery when replacement of the natural crystalline lens with an IOL is indicated. The device is intended to be used by ophthalmic surgeons and their trained operating room staff.

MONARCH™ LOADING FORCEPS

3. Contraindications and undesirable side-effects No contraindications and no undesirable side-effects known when used as intended. 4. Clinical benefits The clinical benefits of this instrument include a design that allows the surgeon to view and verify the lens orientation through the implantation process with simplified loading of the IOL and controlled delivery. 5. Precautions and warnings • Please refer to Alcon delivery system labeling or contact your local Alcon representative for Alcon qualified lens and delivery system product combinations. • The instrument is provided as an unsterile unit and must be processed in accordance with the provided instructions prior to first use and reprocessed after each reuse (see section 7 for details). • If a patient with a prion-related disease undergoes a procedure which,

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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. • Due to the potential for Toxic Anterior Segment Syndrome, Alcon does not recommend the use of enzymatic cleaners, detergents or disinfectant solutions. Therefore, a manual cleaning process using water only is provided. If however, local jurisdictions mandate their use relative to ophthalmic instruments, the enzymatic chemicals, detergents or disinfectant solutions must be completely rinsed / neutralized immediately after processing. • Prior to each use, the instrument must be properly inspected for correct function and damage (see section 6 for details). The end of product life is recognized by appearance of damage or loss of instrument function. The instrument should then be immediately removed from service since a potentially faulty instrument can damage the IOL.

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• Avoid touching hard surfaces with the instrument as this can lead to damage. • Do not use or repair damaged or defective instruments. • Please notify Alcon if any instrument is received damaged or in a defective condition. • Adhere to national regulations when disposing or recycling the product, its components or packaging. • Federal (USA) law restricts this device to sale by or on the order of a physician. SERIOUS INCIDENT REPORTING: Any serious incident related to the use of this medical device should be reported to Alcon Laboratories, Inc.: EU – Contact the local country office or your Alcon distributor Email: [email protected]

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Website: https://www.alcon.com/contact-us Serious incidents should also be reported to the competent authority for medical devices of your Member State. 6. Directions for Use Set-up prior to surgery: Inspect instrument for correct function (proper closing and opening of the forceps), wear and damage (e.g. nicks, dents, corrosion and loss of instrument integrity). The handling of the Alcon Intraocular Lens from its packaging into the MONARCH Cartridge is described below. For additional information, please refer to the product information provided for the Alcon Intraocular Lens and the MONARCH Cartridge.

MONARCH™ LOADING FORCEPS

Steps to follow: 1. Completely fill the MONARCH Cartridge with room temperature viscoelastic (VISCOAT™ ophthalmic viscosurgical device or another viscoelastic which has been qualified by Alcon) as described in the product information provided with the MONARCH Cartridge. Place a drop of viscoelastic on the flat section of the lens packaging and one drop on the center of the lens without touching the optic. 2. Holding the MONARCH Loading Forceps vertically to the packaging, carefully grasp the lens at one of its haptics. Remove the lens from the packaging and place onto the drop of viscoelastic.

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3. Hold the forceps horizontally (with the thinner jaw up). Pick up the lens in the 6 to 12 o’clock orientation about 1/3 and 1/2 way across the optic.

4. Gently insert the lens with its anterior side up until the optic is a little more than half-way inside the cartridge. The lens must be oriented according to the marking on the cartridge.

5 5. Open the forceps and use the thinner jaw to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.

6. Close the forceps and hold them closed for the next three steps.

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7. Using the groove at the distal end of the forceps, take the trailing haptic and gently fold the haptic onto the anterior side of the optic. 8. Keeping the forceps closed, continue to gently push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring that the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic. The forceps will advance the lens into the correct loading position. 9. Retract the forceps to leave the lens in place. 7.

Cleaning, Disinfection and Sterilization

7.1. General Information • Immediately clean instrument after each use. Do not store or allow the instrument to dry after use until thoroughly cleaned. Any dried off remnants, especially saline solution, left on the instruments could trigger irreversible corrosion or other damage.

MONARCH™ LOADING FORCEPS

• Protect the instrument during ultrasonic cleaning and during processing in the washer by use of appropriate instrument trays and holders. No customized equipment required. • Do not clean the instruments with non-ophthalmic devices. • All applied reprocessing procedures must be compatible with stainless steel, titanium and epoxy adhesive. • The instrument should not be exposed to oxidative or low pH cleaning solutions and especially not to NaOCl. Irreparable damage will result. • The instrument should not be exposed to temperatures higher than 140°C (284°F). • The hot instrument should not be chilled in water or other liquid. Allow the instrument to cool by air. • Unless otherwise indicated, the cleaning and disinfection steps should be performed at ambient temperature. • It remains the responsibility of the processor to ensure that the processing as actually performed using equipment, materials and

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personnel in the facility achieves 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 or to your facility’s standard procedures. • Due to the potential for the accumulation of particulate and bioburden residues in the equipment’s water reservoirs, it is the facility’s responsibility to properly maintain the equipment and their associated filters to ensure the introduction of water or steam is contaminant free. • The provided reprocessing instructions have all been validated by Alcon and provide methods for effectively cleaning, disinfecting and sterilizing the MONARCH Loading Forceps per ISO 17664 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices.

• Refer to the safety instructions of cleaning, neutralizing, disinfecting etc. solutions and the equipment used, as well as to the hospital’s hygienic instructions. 7.2. Cleaning Procedure: Manual 7.2.1. Manual Cleaning with Water The following cleaning procedure has been validated by Alcon using an ultrasonic cleaning unit with 35 kHz. Step 1: Submerge instrument in deionized water for a minimum of 5 minutes. Step 2: Flush with running tap water for a minimum of 1 minute. Step 3: Ultrasonic clean with deionized water for a minimum of 5 minutes. Step 4: Rinse with sterile deionized water for a minimum of 1 minute.

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ENGLISH Step 5: Visually inspect to ensure instrument is clean. Repeat steps 1 to 5 as needed. Step 6: Dry the instrument thoroughly with sterile air. Step 7: Visually inspect to ensure the instrument is dry. Step 8: Place the instrument in a packaging suitable for sterilization and protection during storage. Proceed with sterilization.

7.2.2. Manual Cleaning with Detergent The following cleaning procedure has been validated by Alcon with 0.8% CIDEZYME† solution (8 ml per liter of water) using an ultrasonic cleaning unit with 35 kHz. Step 1: Clean in ultrasonic bath filled with the cleaning solution for a minimum of 5 minutes. Step 2: Flush with running tap water for a minimum of 1 minute. Step 3: Ultrasonic clean with sterile deionized water for a minimum of 1 minute.

MONARCH™ LOADING FORCEPS

Step 4: Visually inspect to ensure instrument is clean. Repeat steps 1 to 4 as needed. Step 5: P  roceed with disinfection. Note: If disinfection is not performed immediately, dry the instrument with sterile air until visually dry. 7.3. Disinfection Procedure: Manual The following disinfection procedure has been validated by Alcon with 0.3% CIDEX† OPA solution (3 ml per liter of water) using an ultrasonic cleaning unit with 35 kHz. Step 1: Disinfect in ultrasonic bath filled with fresh disinfectant solution for a minimum of 5 minutes. Step 2: R  inse in ultrasonic bath filled with fresh sterile deionized water for a minimum of 1 minute. Step 3: Repeat step 2 two (2) additional times for a total of three (3) rinses after disinfection.

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Step 4: Dry the instrument thoroughly with sterile air. Step 5: Visually inspect to ensure the instrument is dry. Step 6: Place the instrument in a packaging suitable for sterilization and protection during storage. Proceed with sterilization. 7.4. Cleaning and Disinfection Procedure: Automated Washer The following automated washer procedure has been validated by Alcon with the detergent NEODISHER† MediClean (0.6%, dispensing rate 6 ml per liter of water) and the neutralizer NEODISHER Z (0.1%, dispensing rate 1 ml per liter of water). Step 1: Manually pre-clean by soaking the instrument in deionized water for a minimum of 5 minutes. Step 2: Program the washer to have the following automated cycle. • Wash with detergent at a minimum of 55°C (131°F) for at least 10 minutes. • Neutralize for a minimum of 1.5 minutes.

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 inse with water for a minimum of 5 minutes at 22–27°C R (72°F–81°F), then drain. • Repeat rinse for a minimum of 5 minutes at 22–27°C (72°F–81°F), then drain. • Thermally disinfect at a minimum of 90°C (194°F) for at least 5 minutes. • Dry at a minimum of 100°C (212°F) for at least 5 minutes. Step 3: Visually inspect to ensure instrument is clean. Repeat steps 1 to 3 as needed. Step 4: Visually inspect to ensure the instrument is dry. If required, dry the instrument with sterile air. Step 5: Place the instrument in a packaging suitable for sterilization and protection during storage. Proceed with sterilization. Note: For the automated process use deionized water only.

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7.5. Sterilization Procedure Sterilize the instrument directly after cleaning/disinfection using a steam sterilization cycle validated for these devices by your facility. If any kind of packaging is used during sterilization, it must be suitable for steam sterilization. See table 1 for recommended minimum sterilization parameters that have been validated by Alcon to provide a 10-6 sterility assurance level.

Table 1 – Recommended sterilization cycles Sterilizer Type

Sample Configuration

Minimum Temperature

Minimum Exposure Time (minutes)

Minimum Drying Time (minutes)

Gravity displacement

Wrapped Unwrapped Wrapped Unwrapped Wrapped

132 °C (270°F) 132 °C (270°F) 132 °C (270°F) 132 °C (270°F) 134 °C (273°F)

18 10 4 4 32)

15 NA 16 NA 16

Prevacuum pulsing1)

1) Prevacuum pulsing is based on cycles with 3 pulses. 2) Several European national health authorities recommend a minimal

sterilization time of 18 minutes at 134°C (273°F).

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11 Not made with natural rubber latex

8. Definitions of symbols Consult instructions for use or consult electronic instructions for use Catalogue number Batch code

Manufacturer Date of manufacture Caution, Federal law (USA) restricts this device to sale by or on the order of a physician Medical Device

Non-sterile REUSABLE

Reusable Caution Keep away from sunlight Keep dry

Distributor EC

REP

Authorized representative in the European Community

† Trademark is the property of its respective owner

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Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 USA www.ifu.alcon.com

MONARCH™ LOADING FORCEPS

ZAVÁDĚCÍ PINZETA MONARCH™

Distributor/Dovozce: Alcon Pharmaceuticals (Czech Republic) s.r.o. Na Pankráci 1724/129 140 00, Praha 4 Česká republika Datum revize textu: 03-2020 www.ifu.alcon.com

CZECH

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

© 2020 Alcon Inc.

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2020-03-24