IMPORTANT SAFETY INFORMATION FOR TECNIS® CL 3-PIECE IOLs
TECNIS® CL Silicone intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens. These conditions include: 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 distorted 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, since the clinical study of parent lens model 911A was conducted with the lens implanted in the capsular bag, there are insufficient clinical data to demonstrate the safety and efficacy for placement in the ciliary sulcus, children under the age of 2 years are not suitable candidates for intraocular lenses, the use of silicone lenses in patients with current vitreoretinal disease or those who are at high risk for future vitreoretinal disease that may require silicone oil as part of therapy should be reconsidered. AMO IOLs are single-use medical devices that are labeled with instructions for use and handling to minimize exposure to conditions that may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of AMO 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.
Do not resterilize the lens as this can produce undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 45°C. Do not autoclave the intraocular lens. Avoid exposure to volatile chemicals. Do not reuse the lens.
The most frequently reported adverse event that occurred during the clinical trials of the parent lens models for the TECNIS® CL intraocular lens was corneal edema (upper and lower corneal edema), which occurred at a combined rate of 10.9%. The second most frequent adverse event was iritis, which occurred at a rate of 7.9%. Macular edema was the third most frequently reported adverse event, which occurred at a rate of 3.8%. Other reported reactions occurring in less than 2% of patients were hyphema, secondary glaucoma, cyclitic membrane, vitritis, surgical intervention (penetrating keratoplasty, lens replacement, and lens removal, lens repositioning, wound leak repair, and focal laser therapy), corneal decompensation and endophthalmitis.
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE UNFOLDER® SILVER SERIES IMPLANTATION SYSTEM
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.
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.
See Full Indications and Important Safety Information.
Reference the Directions for Use for a complete listing of Indications and Important Safety Information.