Important Safety Information –TECNIS
®
Toric IOL
Indications: The TECNIS
®
Toric 1-Piece posterior
chamber lenses are indicated for the visual correction
of aphakia and pre-existing corneal astigmatism of
one diopter or greater in adult patients with or without
presbyopia in whom a cataractous lens has been
removed by phacoemulsification and who desire
improved uncorrected distance vision, reduction in
residual refractive cylinder, and increased spectacle
independence for distance vision. The device is
intended to be placed in the capsular bag.
Warnings: Physicians considering lens implantation
should weigh the potential risk/benefit ratio for any
circumstances described in the TECNIS
®
Toric 1-Piece
IOL Directions for Use that could increase complications
or impact patient outcomes. The clinical study did not
show evidence of effectiveness for the treatment of
preoperative corneal astigmatism of less than one
diopter. The TECNIS
®
Toric 1-Piece IOL should not be
placed in the ciliary sulcus. Rotation of the TECNIS
®
Toric 1-Piece IOL away from its intended axis can
reduce its astigmatic correction. Misalignment greater
than 30° may increase postoperative refractive cylinder.
Precautions: Accurate keratometry and biometry in
addition to the use of the TECNIS Toric Calculator
(www.TECNISToricCalc.com) are recommended to
achieve optimal visual outcomes. The safety and
effectiveness of the toric intraocular lens have not been
substantiated in patients with certain preexisting ocular
conditions and intraoperative complications. Refer to
the TECNIS
®
Toric 1-Piece IOL Directions for Use for a
complete description of the preexisting 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
clinical study. Do not reuse, resterilize, or autoclave.
Adverse Events: The most frequently reported
adverse event that occurred with the TECNIS
®
Toric
1-Piece IOL was surgical reintervention, which
occurred at a rate of 3.4% (lens repositioning
procedures and retinal repair procedures). Other
reported events included macular edema, which
occurred at a rate of 2.9% and retinal detachment
which, occurred at a rate of 0.6%.
Caution: Federal law restricts this device to sale by
or on the order of a physician.
Attention: Reference the Directions for Use labeling
for a complete listing of Indications, Warnings and
Precautions.
Learn more at Booth 1626
IOLU-10464 Tecnis Bolts_mech_R3_1.5spread-ASCRSDaily_CTA OPTIONS_v2.indd 2 4/17/13 5:33 PM
TECNIS
®
For your peace of mind.
Introducing the TECNIS
®
Toric IOL
www.TECNISToricIOL.com 1-877-AMO-4-LIFE
