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Indications and Important Safety Information
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Unfolder Platinum 1 Series Implantation System


Text Size: SM / MD / LG

THE UNFOLDER PLATINUM 1 SERIES IMPLANTATION SYSTEM

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Designed for the micro-implantation procedure and compatible across the full range of TECNIS® 1-Piece Diopters


unfolder

unfolder platnum 1 series cartridge

unfolder platnum 1 series handpiece

Loading the Unfolder Platinum 1 Series CartridgeUnfolder Platinum 1 Steps

tips for lens insertion

Indications and Important Safety Information

UNFOLDER Platinum 1 Series Implantation System

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

Indications
The UNFOLDER Platinum 1 Series Implantation System is used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses (IOL), ONLY into the capsular bag.

Warnings
The UNFOLDER Platinum 1 Series 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. The Model 1MTEC30 cartridge is intended for single use only. AMO single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient or the user. 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.

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