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TECNIS® Multifocal Toric II IOL +3.25 D

TECNIS® Multifocal Toric II IOL +3.25 D

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the TECNIS® Multifocal Toric II IOLs

Rx Only

 

INDICATIONS 

The TECNIS® Multifocal Toric II lens models ZKU150, ZKU225, ZKU300, ZKU375 and ZLU150, ZLU225, ZLU300, ZLU375 are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with or without presbyopia, with greater than or equal to 1 diopter of preexisting corneal astigmatism, in whom a cataractous lens has been removed in order to provide near, intermediate and distance vision. The IOLs are intended for capsular bag placement only.

 

WARNINGS

Physicians considering lens implantation should weight the potential risk/benefit ratio for any conditions described in the Directions for Use that could increase complications or impact patient outcomes.  Multifocal IOL implants may be inadvisable in patients where central visual field reduction may not be tolerated, such as macular degeneration, retinal pigment epithelium changes, and glaucoma. The lens should not be placed in the ciliary sulcus. Inform patients about the possibility that a decrease in contrast sensitivity and an increase in visual disturbances may affect their ability to drive a car under certain environmental conditions, such as driving at night or in poor visibility conditions. The clinical study of the TECNIS® Toric 1-Piece IOL did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter. Rotation of the TECNIS® Multifocal Toric II IOL away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder.

 

PRECAUTIONS

Prior to surgery, inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to patient. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received TECNIS® Multifocal IOL implants. The long term effects of intraocular lens implantation have not been determined.

Accurate keratometry and biometry in addition to the use of the TECNIS® Toric Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes with TECNIS® Multifocal Toric II IOLs. The safety and effectiveness of the toric intraocular lens have not been substantiated in patients with certain preexisting ocular conditions and intraoperative complications. All preoperative surgical parameters are important when choosing a toric lens for implantation. Variability in any of the preoperative measurements can influence patient outcomes. All corneal incisions were placed temporally in the TECNIS® Toric 1-Piece IOL clinical study. Do not reuse, resterilize, or autoclave.

 

ADVERSE EVENTS

Only the rate (3.3%) of surgical re-interventions, most of which were non-lens-related, in the ZLB00 (+3.25 D) lens group, was statistically higher than the FDA grid rate (for both first and second eyes). The most frequently reported cumulative adverse event that occurred during the TECNIS® Toric 1-Piece IOL clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures). 

 

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

PP2020CT4379