Glistenings do exist. But not for enVista.1

The enVista intraocular lens (IOL) is a single-piece ultra-violet absorbing posterior chamber intraocular lens developed to replace the natural crystalline lens in adult patients in whom the cataractous lens has been removed. The enVista IOL has an aspheric optic and is designed to be free of spherical aberration. Give your patients long-term clarity and quality of vision.1-9

The enVista hydrophobic acrylic IOL is the first and only FDA-approved IOL in the U.S. with labeling that states: “No glistenings of any grade were reported for any subject at any visit in the clinical study”.3

Glistenings are fluid-filled microvacuoles that can form within an IOL, and are common in some hydrophobic acrylic IOLs. They cause a portion of the light coming into the eye to be scattered in all directions, and have been shown to have a negative impact on visual acuity.2,10 Additionally, the enVista lens has a low rate of Posterior Capsular Opacification (PCO), a common post-surgical complication with IOLs that causes vision to become clouded post-surgery.1

Slit-lamp photograph of glistenings in a competitive acrylic IOL

glistenings

Key Features & Benefits

Give your patients long-term clarity and quality of vision2-9,11
  • No glistenings were reported at any time in controlled clinical studies1,3
  • Aberration-free aspheric Advanced Optics
  • Minimize PCO1

Exceptional quality of vision2-9

enVista
  • No glistenings were reported at any time in controlled clinical studies1,3
  • Glistenings are prevented and material stability enhanced by:
    • Hydrating the lens to equilibrium water content so that it will neither gain nor lose water
    • Packaging the lens in 0.9% saline solution to eliminate fluid exchange with the aqueous humor4,5
  • Potential for increased resistance to scratches and abrasions6
  • Bausch + Lomb aspheric, aberration-free Advanced Optics provide excellent contrast sensitivity, uniform power, center to edge, and excellent quality vision3, 7-9

Minimize PCO1, 11-13

  • Step-vaulted haptics vault the optic posteriorly for direct contact with the capsular bag
  • Sharp edge design, such as the square edge design present in the Bausch + Lomb AO IOLs, is associated with reduced posterior capsular opacification (PCO) compared to round edge designs11-13
  • 95% at 6 months had no or trace PCO1

stability

Stability and controlled delivery

  • 100% of patients had ≤ 5° of IOL rotation between days 30 and 1801
  • Precise positioning in the capsular bag and removal of viscoelastic are facilitated by controlled unfolding

Specifications:

  • Model Number: MX60
  • Diopter range
    • 0.0 D to +34.0 D (0.0 D to +10.0 D in 1.0-D
      increments; +10.0 D to +30.0 D in 0.5-D increments;
      and +30.0 D to +34.0 D in 1.0-D increments)
  • IOL Master or Immersion A-scan
    • A-Constant 119.1
  • Refractive index
    • 1.54 at 35°C

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:

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

1. Bausch & Lomb Incorporated Study #658 - “A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of a Bausch + Lomb One Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction.” Final Clinical Study Report, dated 24 Aug 2011.
2. Dhaliwal DK, Mamalis N, Olson RJ, et al. "Visual significance of glistenings seen in the AcrySof intraocular lens." J Cataract Refract Surg. 1996;22(4):452-457.
3. enVista Directions for Use.
4. Data on file, Bausch & Lomb Incorporated. Mentak K et al. MD-14 lens material a novel polymer for IOL applications.
5. Data on file, Bausch & Lomb Incorporated. Martin P, Elachchabi A, Goldberg E, Mentak K. Atomic force microscopy (AFM) of IOL surface morphology for dry and hydrated hydrophobic acrylic IOLs. Study Report, July 27, 2006.
6. Mentak K, Martin P, Elachchabi A, Goldberg E. Nanoindentation studies on hydrophobic acrylic IOLs to evaluate surface mechanical properties. Paper presented at: XXV Congress of the European Society of Cataract & Refractive Surgeons (ESCRS); September 8-12, 2007; Stockholm, Sweden.
7. 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.
8. Pepose JS, Qazi MA, Edwards KH, Sanderson JP, Sarver EJ. "Comparison of contrast sensitivity, depth of field 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.
9. Johansson B, Sundelin S, Wikberg-Matsson A, Unsbro 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.
10. Hiroyuki Matsushima, Mayumi Nagata, Yoko Katsuki, Ichiro Ota, Kensaku Miyake, George H.H. Beiko, Andrzej Grzybowski. “Decreased visual acuity resulting from glistening and sub-surface nano-glistening formation in intraocular lenses: A retrospective analysis of 5 cases.” Saudi Journal of Ophthalmology, 2015; 29, 259–263.
11. Nishi O, Nishi K, Osakabe Y. "Effect of intraocular lenses on preventing posterior capsule opacification: design versus material." J Cataract Refract Surg. 2004;30(10):2170-2176.
12. Nixon DR et al. "Pattern of posterior capsule opacification models 2 years postoperatively with 2 single-piece acrylic intraocular lenses." J Cataract Refract Surg. 2010;36:929-934.
13. Buehl, Wolf and Findl, Oliver. “Effect of Intraocular Lens Design on Posterior Capsule Opacification.” J Cataract Refractive Surgery, 2008; 34: 1976-1985.

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