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UNFOLDER® Delivery Systems

INDICATIONS AND IMPORTANT SAFETY INFORMATION

FOR THE UNFOLDER® PLATINUM 1 SERIES IMPLANTATION SYSTEM

Rx Only

INDICATIONS

The Model DK7796 Handpiece is used in combination with the Model 1MTEC30 Cartridge to fold and assist in inserting Johnson & Johnson Surgical 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 JJSV 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. 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 the Model 1MTEC30 Cartridge and JJSV acrylic 1-Piece IOLs. Do not implant lens if rod tip becomes jammed in the cartridge. JJSV 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. The reuse/resterilization/reprocessing of JJSV single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

PRECAUTIONS

The use of viscoelastics is required when loading the IOL into the cartridge. For optimal performance use the JJSV 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 the UNFOLDER®Platinum 1 Series Implantation System has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 41°F or over 86°F.

FOR THE UNFOLDER® EMERALD IMPLANTATION SYSTEM

Rx Only

INDICATIONS

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

WARNINGS

The UNFOLDER® Emerald Series Implantation System should only be used with JJSV 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. 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 in any position within the cartridge for more than 5 minutes. Never reverse the rod direction until the optic body has been completely released. 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 lens may flip and be implanted upside down. The UNFOLDER® Emerald 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 intraocular lens 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.

WARNINGS (CARTRIDGE ONLY)

JJSV 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. The reuse/resterilization/reprocessing of JJSV single-use devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

PRECAUTIONS

Contents are sterile when tray is sealed and undamaged. Overall system performance will be impaired when used in combination with non-JJSV products. The use of viscoelastics is required when loading the IOL into the UNFOLDER® Emerald Cartridge. Do not use balanced salt solution. Do not use if the instrument has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 41°F or over 86°F. Inconsistent results have been found when using some methylcellulose viscoelastics. Avoid using these viscoelastics if high forces are observed while advancing the intraocular lens through the cartridge.

FOR THE UNFOLDER® SILVER SERIES IMPLANTATION SYSTEM

Rx Only

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. If an IOL haptic is caught between the wings of the cartridge, the haptic may become detached from the IOL body during implantation. The lens, cartridge and sheath should be discarded if the lens is in the advanced position for more than 30 seconds or if the lens has been folded in any position 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 UNFOLDER® Silver Series Cartridge is intended for single use only. JJSV 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 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. Never use the UNFOLDER® Silver Series Implantation System without a SofTip Sheath applied to the end of the handpiece rod. Always ensure that the SofTip Sheath is fully engaged on the handpiece rod tip. If it is not, use your sterile-gloved finger to engage the tip firmly against the shoulder of the rod. Avoid methyl cellulose viscoelastics. Follow the dwell recommendations for advanced position of the IOL.

PRECAUTIONS

The contents of the cartridge package are sterile when tray is sealed and undamaged. Overall system performance will be impaired when used in combination with non-JJSV products. The use of viscoelastics is required when loading the IOL into the cartridge. For optimal performance use the JJSV HEALON® Family of Viscoelastics. Do not use balanced salt solution. 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.

ATTENTION

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

PP2018MLT4177