INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE SENSAR® MONOFOCAL 1-PIECE IOL
SENSAR® 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.
Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. Do not reuse lens. 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 113°F (45°C). Do not autoclave the intraocular lens. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded. When the insertion system is used improperly, the haptics of the SENSAR® 1-Piece Lens may become damaged.
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, and 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. 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. The SENSAR® 1-Piece IOL should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus.
The most frequently reported cumulative adverse event that occurred during the clinical trial of the lens was cystoid macular edema, which occurred at a rate of 3.3%. Other reported adverse events include lens exchange and secondary surgical intervention, which occurred at a rate of 0.8%.
Reference the labeling for a complete listing of Important Indications and Safety Information.