The design is distinctive. The outcomes are clear.

Defocus tolerance1 | Glistening-free performance1,2 | Predictable outcomes2

The clear choice for consistent visual excellence. The enVista premium monofocal IOL delivers superb visual acuity, consistent performance, and outstanding patient outcomes.1,2

The eye is not a perfect optical system, due to its visual axis not passing through the center of the cornea, pupil, or lens.3 The enVista premium monofocal IOL has a unique set of features that help compensate for the eye’s natural imperfections and deliver outstanding visual outcomes to a wide range of patients.

Key Features & Benefits

  • Defocus tolerance - Proven performance with the advanced aberration-free optic1,2*
  • Glistening-free performance - No glistenings reported in controlled clinical studies2
  • Predictable outcomes - Excellent contrast sensitivity1† and outstanding visual quality2

Uniquely different. Clearly predictable

enVista® premium monofocal IOL features an advanced, aberration-free optic which enables predictability in achieving desired refractive outcomes.1,2

Utilizing uniform power center-to-edge, enVista compensates for common levels of decentration,1,5-8 and a laboratory study shows that enVista provides a desirable balance of image quality and depth of field.9

Predictably exceptional image quality and contrast sensitivity.

In a laboratory study using an ISO 1 cornea, the residual aberrations are higher with AcrySof IQ and Tecnis IOLs than enVista.1 With its advanced aberration-free optic, enVista delivers increased light throughput compared to AcrySof IQ and Tecnis lenses and predictably provides exceptional image quality and contrast sensitivity regardless of pupil size. 1



Consistent aberration management.

The advanced, defocus tolerant, aberration-free optic on the enVista premium monofocal IOL is less sensitive to decentration compared to negatively aberrated IOLs, resulting in reduced optical aberrations which can degrade retinal image quality.1

Click on image to enlarge:


The best of both worlds–image quality and depth of field.

Now you don’t have to choose between image quality and depth of field. With its advanced aberration-free optic, enVista provides a desirable compromise between depth of field and image quality.9



See the difference smart design can make.

enVista ensures stable performance, predictability, and visual clarity with a unique design and proprietary cryolathing manufacturing process.1

TruSight optic: Glistening-free and potential for resistance to scratches1,2

  • 25x harder material than traditional hydrophobic acrylic lenses for the potential of increased resistance to scratches and abrasions1,10
  • Proven, glistening-free performance2


    Dark field images of AcrySof lens.11* May not be indicative of currently marketed AcrySof lenses.

StableFlex technology: Controlled and efficient unfolding

  • Provides improved material properties to enhance optic recovery1†

AccuSet haptics: Stable centration and performance

  • Step-vaulted haptics with 31% greater capsular bag contact than Tecnis1,14
  • Effective across the full range of lens powers
  • Dependable lens stability and IOL centration1,12
  • Unique haptic fenestrations facilitate intraoperative lens manipulation12
  • 300% more radial compression force than traditional hydrophobic acrylic13

SureEdge design: Continuous 360° posterior square edge

  • A continuous 360° posterior square edge construction has been shown to have the potential benefit of preventing PCO compared to round edge designs16
  • Low long-term PCO incidence: 2.2% capsulotomy rate at 3 years17
  • Cryolathed, microgrooved peripheral edge to help reduce edge glare1

*Images from a laboratory study
†Compared to the previous generation MX60


Specifications:

With its aberration-free optic, glistening-free performance, and predictable outcomes, the enVista premium monofocal IOL is the clear choice for IOL excellence.2

Model Number

 MX60E

Optic Design

Aspheric, aberration-free, biconvex

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*


119.1
5.61 mm
1.85 mm

Other Features

Glistening-free hydrophobic acrylic material
Refractive index: 1.53 at 35° C
UV absorbing
Sharp 360° square posterior edge

Diopter Range

0 to +10 D in 1.0-D increments
+10 to +30 D in 0.5-D increments
+10 to +34 D in 1.0-D increments

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.

BLIS for use with enVista!

BLIS injectorLearn more about BLIS injector system, designed exclusively for use with the enVista IOL. BLIS, complete with a reusable hand piece and single-use cartridge, allows consistent, predictable lens delivery through unenlarged phaco incisions as small as 2.2 mm. 


enVista IOL : Additional information



INDICATIONS:

Indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag.

WARNINGS:

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: 1. Recurrent severe anterior or posterior segment inflammation or uveitis. 2. Patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases. 3. 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). 4. A distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible. 5. Circumstances that would result in damage to the endothelium during implantation. 6. Suspected microbial infection. 7. Children under the age of 2 years are not suitable candidates for intraocular lenses. 8. Patients in whom neither the posterior capsule for zonules are intact enough to provide support.

PRECAUTIONS:

Do not attempt to resterilize the lens as this can produce 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 at a temperature greater than 43°C (110°F). DO NOT FREEZE. Do not autoclave the intraocular lens. Do not reuse the lens. It is intended for permanent implantation. If explanted, sterility and proper function cannot be assured. The safety and effectiveness of the enVista IOL have not been substantiated in patients with preexisting ocular conditions and intraoperative complications. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to divide the benefit/risk ratio before implanting a lens in a patient with one or more preexisting conditions. 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.

ADVERSE EVENTS:

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, 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:

Reference the Directions for Use labeling for a complete listing of indications and important safety information.


References:

1. Data on file. Bausch + Lomb Inc. 2. enVista Directions for Use. 3. Pepose JS. Crystalens AO: Outstanding Refractive Outcomes With High Quality Vision. Ophthalmology Management. Aug 2010. 4. Roach L. Centration of IOLS: Challenges, Variables, and Advice for Optimal Outcomes. EyeNet. Apr 2013. 5. Rynders M, Lidkea B, Chisholm W, Thibos L. Statistical distribution of foveal transverse chromatic aberration, pupil centration, and angle in a population of young adults. J Opt Soc Am. 1995;12(10):2348-2357. 6. Oshika T., et al. Influence of tilt and decentration of scleral-sutured intraocular lens on ocular higher-order wavefront aberration. Br J Ophthalmol 2007;91:185-188. 7. Rosales P, Marcos S. Phakometry and lens tilt and decentration using a custom-developed Purkinje imaging apparatus: validation and measurements. J Opt Soc Am A Opt Image Sci Vis. 2006 ;23(3):509-520. 8. Baumeister M, Neidhardt B, Strobel J, Kohnen T. Tilt and decentration of three-piece foldable high-refractive silicone and hydrophobic acrylic intraocular lenses with 6-mm optics in an intraindividual comparison. Am J Ophthalmol. 2005;140(6):1051-1058. 9. Packer M. enVista hydrophobic acrylic intraocular lens: glistening free. Expert Review of Ophthalmology. 2015; 10:5,415-420. 10. 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. 11. Van der Mooren M, Franssen L, Piers P. Effects of glistenings in intraocular lenses. Biomed Opt Express. 2013 Aug; 4(8):1294–1304. 12. 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. 13. 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. 14. 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. 15. Data on File. Report BLR6540, Rev. A. Bausch & Lomb Incorporated. 16. Buehl W, Findl O. Effect of intraocular lens design on posterior capsule opacification. J Cataract Refract Surg. 2008;34:1976-1985. 17. Tran T. Incidence of Nd:YAG capsulotomy of a hydrophobic glistening-free intraocular lens (MX60). Paper presented at XXXIII Congress of the European Society of Cataract and Refractive Surgeons (ESCRS); September 5-9, 2015; Barcelona, Spain.

EVA.0063.USA.18

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