ONE SERIES ULTRA IMPLANTATION SYSTEM FOR TECNIS® 1-PIECE IOL

The One Series Ultra Implantation System is the only easy-to-use rear-loading cartridge and syringe-style inserter that provides controlled, predictable delivery of the TECNIS® 1-Piece IOL.

Advanced control meets ease-of-use with the One Series Ultra Implantation System:

• Technologically advanced insertion system specifically designed for the next-generation
  TECNIS® 1-Piece IOL
• Easy-to-use, rear-loading One Series Ultra Cartridge
• More controlled lens delivery using a syringe-style inserter with Y-tip plunger rod
• Controlled, gentle unfolding of the lens in the eye

TECNIS® 1-PIECE LOADING OVERVIEW

Indications and Important Safety Information

TECNIS® IOLs

Caution

Federal law restricts this device to sale by or on the order of a physician.

Indications

TECNIS® lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

Warnings

Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens.

Precautions

Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store in direct sunlight or over 45°C.

Adverse Events

Adverse events occurred at rates between 1.6% and 3.3% during the clinical trials for TECNIS® IOLs or their “parent” IOLs. These events included macular edema, endophthalmitis, anterior lens tissue ongrowth, lens dislocation, hypopyon, corneal edema, iritis, hyphema, secondary glaucoma, and secondary surgical intervention.

Attention

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

The One Series Ultra Cartridge Implantation System

Caution

Federal law restricts this device to sale by or on the order of a physician.

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.

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 methyl cellulose 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 AMO 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 5°C or over 30°C.

Contraindications

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

Instructions For Use (Click below for the full version)

TECNIS® 1-Piece IOL IFU (PDF)
One Series Ultra Cartridge 1-Piece IFU (PDF)
HEALON® IFU (PDF)
HEALON GV IFU (PDF)
HEALON5 IFU (PDF)
HEALON® EndoCoat IFU (PDF)

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