enVista toric IOL (Model MX60T)



The Clear Choice for Exceptional Astigmatism Management.

Exacting astigmatism correction. Dependable stability. Pristine visual clarity. It all comes together in the proven enVista platform to deliver:

  • Aberration-free, glistening-free performance1
  • Proven rotational stability1
  • Exceptional outcomes1
  • Delivered through an incision size as small as 2.2mm to limit potential SIA

Extraordinary Aberration-free Optic

*Images may not be indicative of currently marketed AcrySof lenses.


Distinctive Design

  • 300% more radial compression force than traditional hydrophobic acrylic5
  • Step-vaulted haptics provide 31% greater capsular bag contact than Tecnis3,6
  • Unique haptic fenestrations facilitate intraoperative lens manipulation7


Impressive Outcomes



Between form 3-4
At form 4 visit


From Distinctive Design Comes Impressive Stability.

Combining an advanced aberration-free optic with a distinctive design, the enVista toric IOL platform is proven to deliver exceptional rotational stability and excellent outcomes to cataract patients with astigmatism.1

Model Number

 MX60T

Optic Design

Aspheric, aberration-free, biconvex, posterior-surface toric

Optic Size

6 mm

Length

12.5 mm

Haptics

Modified C, fenestrated

Applanation:
Suggested A-constant*
ACD-constant
Surgeon Factor*

118.7
5.37 mm
1.62 mm

Optical Biometry:
Suggested A-constant*
ACD-constant
Surgeon Factor*
Barrett Lens Factor
Barrett Lens Design Factor

119.1
5.61 mm
1.85 mm
1.94
-0.50D

Other Features

Glistening-free hydrophobic acrylic material
Refractive index: 1.54 at 35° C
UV absorbing
Sharp 360° square posterior edge

Diopter Range

+6 D to +30 D in 0.5 D increments

Cylinder Power at IOL Plane

1.25 2.00 2.75 3.50 4.25 5.00 5.75

Cylinder Power at Corneal Plane

0.90 1.40 1.93 2.45 2.98 3.50 4.03

Corneal Astigmatism Correction Range

0.90-1.39 1.40-1.92 1.93-2.44 2.45-2.97 2.98-3.49 3.50-4.02 4.03-4.53

Inserters

BLIS Injector System with incisions as small as 2.2 mm
INJ100 with incisions as small as 2.2 mm


*A-Constants and ACD are estimates only. It is recommended that each surgeon develop his or her own values

 

 

INDICATIONS:

Indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.

WARNINGS:

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio:

  • Recurrent severe anterior or posterior segment inflammation or uveitis.
  • 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 might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss).
  • A distorted eye due to previous trauma or developmental defect 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 zonules are intact enough to provide support.
  • Rotation of enVista toric IOL away from the intended axis can reduce the astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens positioning should occur prior to capsule fibrosis and lens encapsulation.

 

PRECAUTIONS:

  1. Do not attempt to resterilize the lens as this can produce undesirable side effects.
  2. Do not use if product sterility or quality is thought to be compromised due to damaged packaging or signs of leakage (such as the loss of saline storage solution, or the presence of salt crystallization).
  3. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline.
  4. Do not store the lens at a temperature greater than 43°C (110°F) or lower than 0°C (32°F). Do not autoclave the intraocular lens.
  5. Do not reuse the lens. It is intended for permanent implantation. If explanted, sterility and proper function cannot be assured.
  6. The safety and effectiveness of the enVista toric IOL have not been substantiated in patients with preexisting ocular conditions and intraoperative complications (see following list). 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 one or more of these conditions. Physicians considering lens implantation in such patients should explore the use of alternative methods of aphakic correction and consider lens implantation only if alternatives are deemed unsatisfactory in meeting the needs of the patient.

    Before Surgery:
    • Retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or proliferative diabetic retinopathy, in which future treatment may be compromised by implanting this lens.
    • Amblyopia
    • Clinically severe corneal dystrophy (e.g., Fuchs’)
    • Rubella, congenital, traumatic or complicated cataracts
    • Extremely shallow anterior chamber, not due to swollen cataract
    • Recurrent anterior or posterior segment inflammation of unknown etiology, or any disease producing an inflammatory reaction in the eye (e.g. iritis or uveitis).
    • Aniridia
    • Iris neovascularization
    • Glaucoma (uncontrolled or controlled with medication)
    • Microphthalmos or macrophthalmos
    • Optic nerve atrophy
    • Previous corneal transplant
    • Pre-existing ocular conditions which may negatively impact stability of the implant.
    During Surgery:
    • Mechanical or surgical manipulation required to enlarge the pupil
    • Vitreous loss (significant)
    • Anterior chamber bleeding (significant)
    • Uncontrollable positive intraocular pressure
    • Complications in which the IOL stability could be compromised.
  7. Patients with preoperative problems such as corneal endothelial disease, abnormal cornea, macular degeneration, retinal degeneration, glaucoma, and chronic drug miosis may not achieve the visual acuity of patients without such problems. The physician must determine the benefits to be derived from lens implantation when such conditions exist.
  8. A high level of surgical skill is required for intraocular lens implantation. The surgeon should have observed and/or assisted in numerous implantations and successfully completed one or more courses on intraocular lens implantation before attempting to implant intraocular lenses.
  9. As with any surgical procedure, there is risk involved. Potential complications accompanying cataract or implant surgery may include, but are not limited to the following: corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, transient or persistent glaucoma, acute corneal decompensation, toxic anterior segment syndrome (TASS), and secondary surgical intervention. Secondary surgical interventions include, but are not limited to: lens repositioning, lens replacement, vitreous aspiration or iridectomy for pupillary block, wound leak repair, and retinal detachment repair.
  10. Care should be taken to remove all viscoelastic from the anterior and posterior surfaces of the lens, to minimize the possibility of lens rotation causing misalignment of enVista toric IOL from the intended axis placement.
  11. Effectiveness of implanting a toric lens in reducing postoperative astigmatism is affected by many factors, including the following:
    • The degree of mismatch between the postoperative magnitude of corneal astigmatism and effective IOL power in the corneal plane.
    • Misalignment between the intended axial position and final IOL axial orientation.
    • Error in prediction of the postoperative corneal cylinder axis and power. Error in prediction of cylinder axis is greatest for lower levels of preoperative corneal astigmatism.
    • Manufacturing variation in power and axis markings can influence intended correction.

 

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. The enVista toric IOL demonstrated favorable safety compared with the Control IOL and the historical control (cf. ISO 11979-7 SPE) population, with no increase in incidence or severity of adverse events (AEs) compared with the Control IOL and no serious adverse events (SAEs) in the study eye. Overall, no safety signals were associated with the toric IOLs during this study. As with any surgical procedure, risk is involved. Potential adverse events accompanying cataract or implant surgery may include, but are not limited to, the following: corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, transient or persistent glaucoma, acute corneal decompensation, toxic anterior segment syndrome (TASS), and secondary surgical intervention. Secondary surgical interventions include, but are not limited to: lens repositioning, lens replacement, vitreous aspiration or iridectomy for pupillary block, wound leak repair, and retinal detachment repair.

CAUTION:

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

ATTENTION:

This is not all you need to know. Please refer to the Directions For Use labeling for a complete listing of indications, full risk and safety information, clinical study information, etc.



References:
1. enVista Toric Directions for Use. 2. Van der Mooren M, Franssen L, Piers P. Effects of glistenings in intraocular lenses. Biomed Opt Express. 2013 Aug; 4(8):1294–1304. 3. Data on file. Bausch + Lomb Inc. 4. Elachchabi A, Martin P, Goldberg E, Mentak K. Nanoindentation studies on hydrophobic acrylic IOLs to evaluate surface mechanical properties. Paper presented at: XXV Congress of the European Society of Cataract and Refractive Surgeons (ESCRS); September 8-12, 2007; Stockholm, Sweden. 5. Bozukova D, Pagnoulle C, Jerome C. Biomechanical and optical properties of 2 new hydrophobic platforms for intraocular lenses. J Cataract Refract Surg. 2013; 39:1404–1414. 6. FDA.gov. PMA P980040/S015: Summary of Safety and Effectiveness Data (SSED https://www.accessdata.fda.gov/cdrh_docs/pdf/P980040S039b.pdf. Accessed December 7, 2017. 7. Packer M, Fry L, Lavery K, Lehmann R, et al. Safety and effectiveness of a glistening-free single-piece hydrophobic acrylic intraocular lens (enVista). Clin Ophthalmol. 2013;7:1905–1912. 8. Data on File. Report BLR6540, Rev. A. Bausch & Lomb Incorporated. 9. Data on file Bausch & Lomb Study 761.


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