Do not use the lens if the package has been damaged. The sterility of the lens may have been compromised.
Indications for use:
The TECNIS® Symfony IOL, Model ZXR00, is 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 extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. This device is intended to be placed in the capsular bag. The TECNIS® Symfony IOLs, Models ZXT100, ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and preexisting corneal astigmatism in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, a reduction of residual refractive cylinder, and increased spectacle independence. These devices are intended to be placed in the capsular bag.
- Automated examinations may not give reliable results. These may include: autorefractors using infrared light, wavefront sensors, infrared photorefractors, and the Duochrome test. Manifest refraction with maximum plus technique is recommended.
- The ability to perform some eye treatments (e.retinal photocoagulation) and/or examinations (e.autorefraction) may be affected by the TECNIS® Symfony IOL optical design.
- Recent contact lens usage may affect the patient's refraction; therefore, in contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power.
- Do not resterilize the lenMost sterilizers are not equipped to sterilize the soft acrylic material without producing 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 113 °F (45 °CDo not autoclave the intraocular lens.
- Prior to implanting, examine the lens package for proper lens model, dioptric power, and expiration date.
- The surgeon should target emmetropia as this lens is designed for optimum visual performance when emmetropia is achieved.
- Care should be taken to achieve centration of 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 TECNIS® Symfony IOL may become brokePlease refer to the specific instructions for use provided with the insertion instrument or system.
Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio:
- Mild visual effects associated with a TECNIS® Symfony IOL may occur because of the superposition of focused and unfocused images. These may include a perception of halos or glare around lights under nighttime conditions. Preclinical evaluation indicated that these phenomena are comparable to those of a standard monofocal lens.
- Low-contrast image quality may be reduced compared to a monofocal lens. However, preclinical and clinical data indicate that the reduction of image contrast is none to minimal.
- Patients with any of the following conditions may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the patient's eyesight:
- Patients with recurrent severe anterior or posterior segment inflammation or uveitis of unknown etiology, or any disease producing an inflammatory reaction in the eye.
- 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 defects 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.
- Congenital bilateral cataracts
- Previous history of, or a predisposition to, retinal detachment.
- Patients with only one good eye with potentially good vision.
- Medically uncontrollable glaucoma.
- Corneal endothelial dystrophy.
- Proliferative diabetic retinopathy.
- Children under the age of 2 years are not suitable candidates for intraocular lenses.
- The TECNIS® Symfony IOLs should be placed entirely in the capsular bag and should not be placed in the ciliary sulcus.
- Patients should be informed about the possibility of a decrease in contrast sensitivity or an increase in visual disturbances compared to a monofocal IOL.
- The TECNIS® Symfony IOL, Model ZXR00, has not been evaluated for patients with a predicted postoperative astigmatism greater than 1.0 diopter.
- Rotation of toric TECNIS® Symfony IOLs away from their intended axis can reduce their astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.
- Carefully remove all viscoelastic from the capsular bag. Residual viscoelastic may allow the lens to rotate, causing misalignment of the toric TECNIS® Symfony IOL with the intended axis of placement.
- AMO IOLs are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. The resterilization/reprocessing of AMO IOLs 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.
General Adverse Events for IOLs
Potential adverse events during or following cataract surgery with implantation of an IOL may include but are not limited to:
- Endophthalmitis/intraocular infection
- IOL dislocation
- Pupillary block
- Retinal detachment
- Persistent corneal stromal edema
- Persistent cystoid macular edema
- Secondary surgical intervention (including implant repositioning, removal, AC tap, or other surgical procedure)
- Any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment
Reference the Directions for Use for a complete listing of indications, warnings, and precautions.
Not all products, services or offers are approved or offered in every market and approved labeling and instructions may vary from one country to another.
TECNIS, TECNIS Symfony, ProTEC, Tri-Fix, UNFOLDER, and ONE SERIES are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.
©2014 Abbott Medical Optics Inc., Santa Ana, CA 92705