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One Series Ultra Delivery System

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE ONE SERIES ULTRA CARTRIDGE IMPLANTATION SYSTEM

Rx Only

INDICATIONS

The DK7786 handpiece with the One Series Ultra cartridge implantation system is used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses (IOL), ONLY into the capsular bag.

CONTRAINDICATIONS

Do not use the handpiece if the rod tip appears nicked or damaged in any way.

WARNINGS

The DK7786 handpiece with the One Series Ultra cartridge implantation system should only be used with TECNIS® 1-Piece IOLs. Do not use if the cartridge tip is cracked or split prior to implantation. Never release the plunger until the optic body has been completely released from the cartridge tube. The lens and cartridge should be discarded if the lens has been folded within the cartridge for more than 5 minutes. If the IOL is not properly placed in the cartridge, the IOL may be damaged and/or implanted upside down. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design. Use of methylcellulose viscoelastics is not recommended as they have not been validated with this implantation system. Do not implant lens if rod tip becomes jammed in the cartridge.

PRECAUTIONS

The use of viscoelastics is required when loading the IOL into the cartridge. For optimal performance use the HEALON® Family of Viscoelastics. Do not use balanced salt solution. The combination of low operating room temperatures and high IOL diopter powers may require a slower delivery. Do not use if any component of this implantation system has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 41°F (5°C) or over 86°F (30°C).

ATTENTION

Reference the labeling for a complete listing of Indications and Important Safety Information.

PP2018MLT4018