INTREPID TRANSFORMER I/A HANDPIECE Directions for Use

TRANSFORMER I/A HANDPIECE DIRECTIONS FOR USE DESCRIPTION and CHARACTERISTICS of the DEVICE The IntrepidTM Transformer I/A handpiece is an accessory to the CenturionTM Vision System used in the removal of cortical material during small incision cataract lens extraction. The Intrepid Transformer I/A handpiece is a single handpiece that can be transformed to either Coaxial mode or Bimanual mode. It is packaged and shipped in the Coaxial mode in which the Transformer I/A handpiece works as a single unit which performs both irrigation and aspiration simultaneously. In Bimanual mode, the Transformer I/A handpiece has two pieces which work simultaneously to remove fluid and tissue from the eye through one unit, while the other one pumps BSS into the eye. All fluid path components of the handpiece are made of Polycarbonate, Stainless Steel and Silicone. The Intrepid Transformer I/A handpiece is a single use device and is packaged and delivered sterile for use in lens removal procedures. INTENDED USE – INDICATIONS for USE The Intrepid Transformer I/A handpiece is intended for use in conjunction with a compatible Alcon phacoemulsification system to perform cataract removal surgery. The Intrepid Transformer I/A handpiece is indicated for use in ophthalmic procedures that require simultaneous lens extraction, irrigation, and aspiration. The Intrepid Transformer I/A handpiece is intended for patients who require ophthalmic surgery consistent with the indications for use. The intended users are licensed ophthalmic surgeons and their trained operating room staff. CLINICAL BENEFITS The clinical benefits of the Intrepid Transformer I/A handpiece include facilitating phacoemulsification cataract surgery in ophthalmic anterior segment procedures. CONTRAINDICATIONS No contraindications for the device have been established. WARNINGS 1. Check the system settings and test for adequate irrigation and aspiration flow prior to entering the eye. The use of settings with insufficient flow characteristics may result in a fluidic imbalance and may cause a shallowing or collapsing of the anterior chamber. 2. The equipment used in conjunction with the Alcon Intrepid Transformer I/A handpiece constitutes a complete surgical system. Use of disposables other than those approved by Alcon may affect system performance and cause physical injury to patient and/or end user. 3. Inspect the tip(s) for the handpiece product prior to use: If there is excessive bending and/or any damage to the tip, do not use product. Use of damaged or deformed tip may cause ocular tissue damage and/or inflammation. 4. Inspect the handpiece for damages (e.g. nicks, crimps, dents). If the handpiece is damaged, immediately remove it from service. Use of damaged handpiece may result in serious permanent patient injury. 5. The Intrepid Transformer I/A handpiece is indicated for use with Centurion Vision System. The fluidics performance of other consoles may be insufficient to perform Micro Co-axial cataract procedures. 6. Do not use the product after expiration date marked on the product’s packaging labels. Use of expired product could result in inflammation, infection, or tissue damage. 7. The reuse/resterilization/reprocessing of Alcon single-use devices may result in damage to the medical device, and failure of the medical device to perform as intended. Furthermore, damaged instrument could cause ocular tissue damage and/or inflammation or infection. 8. The Intrepid Transformer I/A handpiece is intended for single phacoemulsification procedure only. Improper usage or assembly could result in patient and/or user injury. PRECAUTIONS 1. Do not use if the device is received in a defective condition or has been unintentionally opened. Do not use any of the contents if the sterile package is damaged or the seal is broken in any way. In these cases, please contact: By Phone: By Website: In USA-(800) 757-9780

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

In EU/International: Contact your local Alcon Representative. Each handpiece is identified by a lot number which provides traceability and should be given to your local Alcon representative when discussing the Intrepid Transformer I/A handpiece. 2. Potential risk from reuse or reprocessing include: presence of tip burrs, fluid path leaks or obstruction resulting in reduced fluidics performance, and foreign particle introduction into the eye. DIRECTIONS FOR USE The Directions-for-Use is intended to supplement the system Operator’s Manual. The manual includes in-depth information for familiarizing the operating room staff with the controls and functions of the instrument. Refer to driving instrument Operator’s Manual for handpiece setup and priming instructions.

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SETUP:

COAXIAL MODE:

TO SEPARATE: REMOVE FROM EYE. TWIST COUNTER CLOCKWISE TO UNLOCK. THEN PULL APART.

BIMANUAL MODE:

REJOIN HANDLES TO RETURN TO COAXIAL MODE. TO REJOIN: REMOVE FROM EYE. CAREFULLY INSERT ASPIRATION TIP INTO BACK OF IRRIGATION HANDLE. PUSH FORWARD TO FULLY ENGAGE LOCKING TABS. THEN GENTLY TWIST CLOCKWISE TO RELOCK. PACKAGING AND STERILIZATION The IntrepidTM Transformer I/A handpiece is a single use device, packaged in a PETG blister sealed with Tyvek lid stock, provided sterile (gamma irradiation). Each package contains 6 individually sealed units. SERIOUS INCIDENT REPORTING Any serious incident related to the use of this medical device should be reported to Alcon Laboratories Inc.: By Phone: In USA - (800) 757-9780 EU / International - Contact the local country office or your Alcon distributor. Website:

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

In EU, by Email: [email protected] These serious incidents should also be reported to the competent authority for medical devices of your State. DEFINITIONS Definitions for symbols that appear on product labels: CONSULT INSTRUCTIONS FOR USE OR CONSULT ELECTRONIC INSTRUCTIONS FOR USE

MANUFACTURER

CATALOG NUMBER

DATE OF MANUFACTURE

BATCH CODE

COUNTRY OF MANUFACTURE

MEDICAL DEVICE

OPEN HERE

DOES NOT CONTAIN LATEX OR DRY NATURAL RUBBER

USE BY: YYYY-MM-DD

DO NOT REUSE

DO NOT RESTERILIZE

AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

DO NOT USE IF PACKAGE IS DAMAGED

CAUTION: U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN SINGLE STERILE BARRIER SYSTEM STERILE - STERILIZED BY IRRADIATION

www.ifu.alcon.com

© 2021 Alcon Inc.

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

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LANGUAGES NOT TRANSLATED: [BG] - BULGARIAN / БЪЛГАРСКИ [CS] - CZECH REPUBLIC / ČESKY [ET] - ESTONIAN / EESTI [EL] - GREEK / EΛΛHNIKA [HU] - HUNGARIAN / MAGYAR [LV] - LATVIAN / LATVIEŠU [LT] - LITHUANIAN / LIETUVIŠKAI [PL] - POLISH / POLSKI [RO] - ROMANIAN / ROMÂNĂ [RU] - RUSSIAN / РУССКИЙ

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

300051080 REV. A ISSUED: 25-APR-2022