Important Safety Information – The UNFOLDER® Silver Handpiece with the One Series Cartridge Implantation System
Federal law restricts this device to sale by or on the order of a physician.
The UNFOLDER® Silver handpiece with the One Series cartridge implantation system is used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses (IOL), ONLY into the capsular bag.
Warnings: The UNFOLDER® Silver handpiece with the One Series 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. The lens and cartridge should be discarded if the lens is in the advanced position for more than 30 seconds or if the lens has been folded within the cartridge for more than 5 minutes. If an IOL haptic is caught between the wings of the cartridge, the haptic may become detached from the IOL body during implantation. If the IOL is not properly placed in the cartridge, the IOL may flip and be implanted upside down. The UNFOLDER® One Series cartridge is intended for single use only. Discard after a single use. Do not autoclave or resterilize by any method. Do not advance an IOL through a given cartridge more than once. 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: Contents are sterile when pouch is sealed and undamaged. Overall system performance will be impaired when used in combination with non-AMO products. The usage of viscoelastics is required when loading the IOL into the UNFOLDER® One Series cartridge. Do not use balanced salt solution. Do no use if the instrument 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. For optimal performance use the AMO HEALON® Ophthalmic Viscoelastic solution.
Contraindications: Do not use the handpiece if the rod tip appears nicked or damaged in any way.