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INDICATIONS AND IMPORTANT SAFETY INFORMATION

Rx Only

FOR THE TECNIS® 1-PIECE IOL WITH THE TECNIS iTEC® PRELOADED DELIVERY SYSTEM
INDICATIONS

The TECNIS® 1-Piece Lens is 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 following circumstances should weigh the potential risk/benefit ratio. Patients with recurrent severe anterior or posterior segment inflammation or uveitis; patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL; children under the age of 2 years are not suitable candidates for intraocular lenses.

See Full Indications and Important Safety Information.

FOR THE UNFOLDER® PLATINUM 1 SERIES IMPLANTATION SYSTEM
INDICATIONS

The Model DK7796 Handpiece is used in combination with the Model 1MTEC30 Cartridge to fold and assist in inserting AMO Acrylic 1-Piece Intraocular Lenses, ONLY into the capsular bag. 

CONTRAINDICATIONS

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

WARNINGS

The UNFOLDER® Platinum 1 Series Implantation System should be used ONLY with AMO Acrylic 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.

See Full Indications and Important Safety Information.

FOR THE UNFOLDER® EMERALD SERIES IMPLANTATION SYSTEM
INDICATIONS

The UNFOLDER® Emerald Series Implantation System is used to fold and assist in inserting AMO acrylic intraocular lenses, ONLY into the capsular bag.

WARNINGS

The UNFOLDER® Emerald Series Implantation System should only be used with AMO acrylic OptiEdge IOLs. Do not use this device or any of its components with any other lens. If the cartridge tip is cracked or split prior to implantation, do not use.

See Full Indications and Important Safety Information.

FOR THE UNFOLDER® SILVER SERIES IMPLANTATION SYSTEM
INDICATIONS

The UNFOLDER® Silver Series Implantation System is used to fold and assist in inserting CLARIFLEX, PHACOFLEX II, CeeOn, TECNIS® Silicone, and ARRAY Silicone ≤ 24.0 D IOLs only, into the eye. 

WARNINGS

The UNFOLDER® Silver Series Implantation System should only be used with silicone IOLs. Do not use this device or any of its components with any other lens. If the cartridge tip is cracked or split prior to implantation, do not use. Never release the rod direction until the optic body has been completely released.

See Full Indications and Important Safety Information.

FOR THE ONE SERIES ULTRA IMPLANTATION SYSTEM
INDICATIONS

Either the DK7786 or DK7791 handpiece is used in combination with the ONE SERIES Ultra Cartridge to fold and assist in inserting AMO Acrylic 1-Piece intraocular lenses, 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/DK7791 Implantation System should ONLY be used with AMO Acrylic 1-Piece IOLs. Do not use if the cartridge tip is cracked or split prior to implantation. with hyperlink to full safety.

See Full Indications and Important Safety Information.

ATTENTION

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

PP2018MLT4018