INDICATIONS AND IMPORTANT SAFETY INFORMATION - TECNIS® 1-Piece IOL with the TECNIS iTec Preloaded Delivery System
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
ATTENTION: Reference the Directions for Use labeling for a complete listing of indications and important safety information.
INDICATIONS: AMO TECNIS® 1-piece lenses are 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.
PRECAUTIONS: Do not resterilize the lens or the TECNIS iTec Preloaded Delivery System. Most sterilizers are not equipped to sterilize the soft acrylic material and the preloaded inserter material without producing undesirable side effects. Do not store the device in direct sunlight or at a temperature under 5°C (41°F) or over 35°C (95°F). Do not autoclave the device. Do not advance the lens unless ready for lens implantation. The contents are sterile unless the package is opened or damaged. The recommended temperature for implanting the lens is at least 17°C. The combination of low operating room temperatures and high IOL diopter powers may require slower delivery. The use of viscoelastics is required when using the TECNIS iTec Preloaded Delivery System. For optimal performance, use the AMO HEALON® family of viscoelastics. The use of balanced salt solution alone is not recommended. Do not use if the TECNIS iTec Preloaded Delivery System has been dropped or if any part was inadvertently struck while outside the shipping case.
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. Do not attempt to disassemble, modify or alter this device or any of its components, as this can significantly affect the function and/or structural integrity of the design. Use of methylcellulose viscoelastics is not recommended as they have not been validated for use with the TECNIS iTec Preloaded Delivery System. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the cartridge. Do not push the plunger forward to fully advance the lens until ready for lens implantation. Discard the device if the lens has been fully advanced for more than 1 minute. 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. When used according to the directions for use, the TECNIS iTec Preloaded Delivery System minimizes the risk of infection and/or inflammation associated with contamination. The reuse/resterilization/reprocessing of AMO 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. The TECNIS® 1-piece IOL should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus.
ADVERSE EVENTS: The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece IOL was cystoid macular edema, which occurred at a rate of 3.3%. Other reported events occurring in less than 1% of patients were secondary surgical intervention (0.8%, vitrectomy) and lens exchange (0.8%, due to torn lens haptic).