Trulign Toric IOL

The first lens to bring astigmatism AND presbyopia into focus.

TRULIGN Toric IOL offers the critical advantages your patients need:

  • Full range of vision
  • Proven stability
  • Minimized dysphotopsias

The first FDA-approved Toric IOL in the US that corrects for astigmatic and presbyopia with a broad range of vision. Providing a new direction for your astigmatic and presbyopic cataract patients, the innovative TRULIGN Toric IOL features an advanced aspheric optic for exceptional visual acuity extending from midrange to distance. 

The Bausch + Lomb Trulign Toric Posterior Chamber Intraocular Lens is a modified plate haptic lens with hinges across the plates adjacent to the optic. Trulign Toric lens Model BL1UT has an aspheric front (anterior) surface with alignment marks and an aspheric toric back (posterior) surface.

Key Features & Benefits

  • Provides a high quality, sharp, clear vision
  • Excellent acuity and contrast1,2
  • Minimizes glare2
  • Uniform power, center to edge, for predictable results3-5

Characteristics of Trulign Toric Posterior chamber intraocular lens:

 

 

Model

Feature

BL1UT

Power Range

+4.0 to +10.0 Diopters (1.0 Diopter Increments) SE
+10.5 to +33.0 Diopters (0.5 Diopter Increments) SE
SE - Spherical Equivalent

Cylinder Powers 1.25, 2.00, 2.75 Diopters (CYL)
Anterior Surface  Asperic with Axis-mark
Posterior Surface  Aspheric Toric
Overall Diameter 11.5mm
Optic Diameter 5.0mm
Plate Overall 10.5mm
Plate Configuration Rectangular
Material-body and Plates  Silicone (10% UV Cutoff at 400nm)
Loop (haptic) material Polyimide
Index of Refraction at 546nm 1.4301
Delivery System Crystalsert Delivery System
 

 

INDICATIONS FOR USE:

The TRULIGN Toric posterior chamber intraocular lens (IOL) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia who desire reduction of residual refractive cylinder with increased spectacle independence and improved uncorrected near, intermediate and distance vision.

PRECAUTIONS:

Careful preoperative evaluation and sound clinical judgement should be used by the surgeon to decide the risk / benefit ration before implanting a lens in a patient. Rotation of toric lenses away from their intended axis can reduce their effectiveness, and misalignment can increase postoperative refractive cylinder. The TRULIGN Toric IOL should only be repositioned when the refractive needs of the patient outweigh the potential risks inherent in any surgical reintervention into the eye. Unlike most other IOLs, the TRULIGN Toric IOL optic has hinges connecting it to the haptic; please see adverse events section below for more information.

PRECAUTIONS:

The safety and effectiveness of the TRULIGN Toric intraocular lenses have not been substantiated in patients with preexisting ocular conditions and intraoperative complications. Long-term stability in the human eye has not been established; therefore postoperative monitoring after implant should be performed on a regular basis. Lens rotation less than 5° may not warrant reorientation. Do not resterilize this intraocular lens by any method. Do not store lenses at temperatures over 45°C (113°F). Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with conditions as outlined in the TRULIGN Toric IOL directions for use.

ADVERSE EVENTS:

The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control (“FDA grid”) population. As with any surgical procedure, risk is involved. Vaulting is a post-operative adverse event where the TRULIGN Toric IOL optic hinges move into and remain in a displaced configuration. If vaulting occurs, please see Directions for Use for a detailed listing of symptoms, information regarding diagnosis, potential causes, and sequelae. Physicians should consider the characteristics of each individual vaulting case prior to determining the appropriate treatment. Data on long-term follow-up after treatment of vaulting is not available.

ATTENTION:

Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION:

Federal (USA) law restricts this device to the sale by or on the order of a physician.


REFERENCES:
1. Data on file, Bausch & Lomb Incorporated. Study 650.
2. TRULIGN  Toric IOL Directions for Use.
3. Santhiago MR, Netto MV, Barreto J Jr, et al. Wavefront analysis, contrast sensitivity, and depth of focus after cataract surgery with aspherical intraocular lens implantation. Am J Ophthalmol. 2010;149(3):383-389.
4. Pepose JS, Qazi MA, Edwards KH, Sanderson JP, Sarver EJ. Comparison of contrast sensitivity, depth of fi eld and ocular wavefront aberrations in eyes with an IOL with zero versus positive spherical aberration. Graefe’s Arch Clin Exp Ophthalmol.2009;247(7):965-973.
5. Johansson B, Sundelin S, Wikberg-Matsson A, Unsbo P, Behndig A. Visual and optical performance of the Akreos Adapt Advanced Optics and Tecnis Z9000 intraocular lenses: Swedish multicenter study. J Cataract Refract Surg.2007;33(9);1565-1572.

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