With its unique design, the UNFOLDER Platinum 1 Series handpiece provides precise controlled delivery.
The UNFOLDER Emerald XL Delivery System is engineered to simplify implantation while maximizing your control. With larger hand wheel, screw-style implantation technique and small threads, it delivers with exceptional control.
| UNFOLDER™ Platinum 1 Series Delivery System | UNFOLDER™ Emerald XL Delivery System | |
|---|---|---|
Compatible With | TECNIS™ 1-Piece IOLs | TECNIS™, SENSAR™ and 3-Piece IOLs |
Incision Size | 2.2-2.4. mm | 2.8 mm |
Delivery System | Screw-style | Screw-style |
Loading | Rear-loading cartridge | Cartridge-loading platform |
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 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 J&J 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 J&J acrylic 1-Piece IOLs. Do not implant lens if rod tip becomes jammed in the cartridge. J&J 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 J&J 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 J&J 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.
Rx Only
INDICATIONS:
The UNFOLDER™ Emerald Series implantation system is used to fold and assist in inserting Johnson & Johnson, Inc. acrylic intraocular lenses, ONLY into the capsular bag.
CONTRAINDICATIONS:
None.
WARNINGS:
The UNFOLDER™ Emerald Series implantation system should only be used with Johnson & Johnson, Inc. 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): Johnson & Johnson, Inc. 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 Johnson & Johnson, Inc. 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
(Cartridge Only): Contents are sterile when tray is sealed and undamaged. Overall system performance will be impaired when used in combination with non-Johnson & Johnson, Inc. 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 (5°C) or over 86°F (30°C). 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.
ATTENTION:
Reference the labeling for a complete listing of Indications and Important Safety Information.
