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Phacoemulsification Packs

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE FUSION® DUAL PUMP PACK (OPO73)

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INDICATIONS

The DUAL PUMP Pack contains the tubing sets and manifold and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the WHITESTAR Signature®or WHITESTAR SIGNATURE® PRO Systems (“WHITESTAR Signature®  System(s)”). The DUAL PUMP Pack is sterilized using ethylene oxide and is designed for single use only.

WARNING

Single use only. Do not re-sterilize, reprocess, or reuse this device.

PRECAUTIONS

Do not use product after its expiration date marked on product’s packaging labels. Contents are sterile when product tray is sealed with lid and undamaged. Do not resterilize and do not reuse. Only use this DUAL PUMP Pack with the WHITESTAR Signature® Systems. Overall system performance may be impaired when used in combination with non-AMO products. If product performance becomes compromised during use, discontinue use and perform the appropriate tests as detailed in the Operator’s Manual. If results are not satisfactory, replace the DUAL PUMP Pack according to instructions defined in the Operator’s Manual.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR MULTIPLE-USE PACK (OPO85)

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INDICATIONS

The OPO85 is used with the COMPACT INTUITIV System. The OPO85 is sterilized using Ethylene Oxide and is designed for use up to 20 times. Following the first use, the user then follows cleaning and sterilization instructions specified below for up to 19 additional cleaning/sterilization cycles for a total of 20 uses when used according to the Instructions for Use.

CAUTION

Do not sterilize the OPO85 prior to performing the cleaning procedure described in OPO85 Directions for Use.

WARNINGS

Sterility assurance is the responsibility of the user. The use of gas resterilization is not recommended. If the OPO85 is received in an unsatisfactory condition, please contact your local AMO Sales Office immediately. Each OPO85 is identified by a lot number and this should be included in any correspondence or discussions.

PRECAUTIONS

Contents are sterile when tray is sealed and undamaged. Only use the OPO85 with the COMPACT INTUITIV System. Overall system performance may be impaired when used in combination with non-AMO products. If product performance becomes compromised during use; discontinue use and perform the appropriate steps as detailed in the Operator’s Manual. If results are not satisfactory, replace the OPO85 according to instructions defined in the Operator’s Manual. Improper/inadequate cleaning may result in particulate matter adhering to the internal surfaces of the tubing and MANIFOLD. As a result, the functionality of OPO85 may become compromised. After a maximum of 20 uses (19 reuses), the OPO85 must be discarded. The OPO85 has not been tested past 20 uses. Always ensure proper COMPACT INTUITIV System settings are used with the OPO85. Only use approved OPO85 accessories.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE WHITESTAR SIGNATURE® PRO SYSTEM

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INDICATIONS

The WHITESTAR SIGNATURE® PRO System is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery. The modular design allows the users to configure the system to meet their surgical requirements.

WARNINGS

Read and understand the instructions in this manual before they use the system. Failure to do so might result in the improper operation of the system. Only a trained licensed physician can use this device.

See Full Indications and Important Safety Information.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE COMPACT INTUITIV SYSTEM

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INDICATIONS

The COMPACT INTUITIV System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Single-Use Pack is used with the COMPACT INTUITIV System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.

WARNINGS

All personnel should read and understand the instructions in the COMPACT INTUITIV System operator’s manual before they use the system. Failure to do so may result in the improper operation of the system. Only a trained and licensed physician is to use this device.

See Full Indications and Important Safety Information.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE WHITESTAR SIGNATURE®SYSTEM

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INDICATIONS

The AMO WHITESTAR Signature® Phacoemulsification System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements.

IMPORTANT SAFETY INFORMATION

Risks and complications of cataract surgery may include broken ocular capsule or corneal burn. This device is only to be used by a trained licensed physician.

WARNINGS

Read and understand the instructions in this manual before they use the system. Failure to do so might result in the improper operation of the system. Only a trained licensed physician can use this device.

See Full Indications and Important Safety Information.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE SOVEREIGN® COMPACT PHACOEMULSIFICATION SYSTEM

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INTENDED USE

The SOVEREIGN® Compact Cataract Extraction System is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

WARNINGS

All personnel should read and understand the instructions in this manual before the system is used. Failure to do so may result in the improper operation of the system. This device is only to be used by a trained licensed physician. DO NOT attempt to use the system if it fails to perform properly as stated in this manual.

See Full Indications and Important Safety Information.

ATTENTION

Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

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