TECNIS® Multifocal intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses 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. Some visual effects associated with multifocal IOLs may be expected because of the superposition of focused and unfocused images. These may include a perception of halos/glare around lights under nighttime conditions. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low illumination conditions. On rare occasions, these visual effects may be significant enough that the patient will request removal of the multifocal IOL. The splitting of the light into more than one focus may affect image quality and lead to some reduction of contrast sensitivity. Under low-contrast conditions, contrast sensitivity is reduced with a multifocal lens compared to a monofocal lens. Therefore, patients with multifocal lenses should exercise caution when driving at night or in poor visibility conditions. Patients with a predicted postoperative astigmatism >1.0 D may not be suitable candidates for multifocal IOL implantation since they may not fully benefit from a multifocal IOL in terms of potential spectacle independence. Care should be taken to achieve IOL centration as lens decentration may result in patients experiencing visual disturbances, particularly in patients with large pupils under mesopic conditions.
The central one-millimeter area of the lens creates a far image focus, therefore patients with abnormally small pupils (~1 mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however, because this multifocal design has not been tested in patients with abnormally small pupils, it is unclear whether such patients will derive any near vision benefit. Autorefractors may not provide optimal postoperative refraction of multifocal patients; manual refraction is strongly recommended. In contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Care should be taken when performing wavefront measurements as two different wavefronts are produced (one will be in focus [either far or near] and the other wavefront will be out of focus); therefore incorrect interpretation of the wavefront measurements is possible. The long-term effects of intraocular lens implantation have not been determined; therefore implant patients should be monitored postoperatively on a regular basis. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. The intraocular pressure of implant patients with glaucoma should be carefully monitored postoperatively. Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store in direct sunlight or over 45° C. Emmetropia should be targeted as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve centration.
The most frequently reported adverse event that occurred during the clinical trial of the TECNIS® Multifocal lens was surgical reintervention, which occurred at a rate of 3.7% in first eyes (lens-related 0.6%; non–lens-related 3.2%). Secondary surgical intervention included lens exchange, retinal repair, iris prolapse/wound repair, trabeculectomy, lens repositioning, and lens removal due to patient dissatisfaction. A total of three subjects (0.9%; 3/348) underwent lens-related lens removal (in first and second eyes); two lens removals were due to halos/glare and one was due to image quality (blurry/hazy vision). The second most reported adverse event reported was macular edema, which occurred at a rate of 2.6%. Other reported adverse events were hypopyon, endophthalmitis, and persistent raised intraocular pressure requiring treatment, each occurring in 0.3% of subjects, respectively.
Reference the Directions for Use for a complete listing of indications, warnings, and precautions, and adverse events.
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