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Clareon® IOL with AutonoMe® Automated Delivery System

 

Deliver the latest evolution of control and clarity1-3

 

Clareon® IOL with AutonoMe® Automated Delivery System

 

Deliver the latest evolution of control and clarity1-3

IMPORTANT PRODUCT INFORMATION

Designed for precise IOL delivery with easy, intuitive control

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Easy: Single-handed
control of IOL delivery1,4*,†

 

  • Innovative, automated CO2-powered delivery mechanism
  • Integrates a responsive speed control lever
  • Precisely start, stop and vary the speed of delivery at any time
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Intuitive: Designed for comfortable, ergonomic hand positions4

 

  • Entire device is optimized for intuitive control of IOL delivery
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Control: Designed to enable precise delivery into the capsular bag4

 

  • Designed to protect incisions as small as 
2.2 mm with a proprietary depth guard2,4,5
  • Designed to provide full IOL visibility during delivery with a 3 mm nozzle tip

Ready to implant in just 3 steps1‡,§

 

Once the IOL is in the pause location, the lens should be implanted within 1 minute.

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Step 1:

 

Fill with an Alcon-qualified viscoelastic

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Step 2:

 

Remove the lock-out assembly

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Step 3:

 

Advance the plunger to fold the IOL up to the pause location

Available with the Clareon® Monofocal, Clareon® Monofocal Toric and Clareon® PanOptix® IOLs 

 

Clareon® Monofocal IOLs provide exceptional clarity**, allowing you to confidently deliver the long-lasting refractive outcomes that your monofocal patients expect.3,6

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Exceptional Clarity that Lasts3,6††
 

Delivers among the lowest levels of glistenings, SSNGs, and surface haze.3,6-8†† In long-term clinical studies, Clareon® IOLs were reported as glistening-free over 3 and 9 years.6,9††

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Proprietary Precision Edge Design10
 

Proprietary edge curvature designed to help reduce PCO and edge glare.1,10-12

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Superior Axial Stability1,13,14‡‡

 

 

Fibronectin helps bind the material to the capsule, anchoring the lens in place to help reduce PCO and improve stability.10,13,15

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Optical Design with Proven Performance16,17§§

 

Clareon® and AcrySof® share the same -0.2µm aspheric design resulting in improved depth of focus with a fully usable 6mm optic.17§§

Available on Clareon®: Alcon’s most advanced IOL biomaterial to date

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* Based on feedback from 112 surgeons, following implantation of Clareon® IOLs in porcine eyes using the AutonoMe® delivery device via clear corneal incisions. 
† Based on ranking of ease of use compared to current Alcon delivery device; options included “easier” (68%), “the same” (28%), and “more difficult” (4%). 
‡ For full preparation and administration information, please refer to the directions.

§ For Use for Clareon® IOL and AutonoMe® Delivery System.

** Based on in vitro examinations of glistenings, surface haze and SSNGs.

†† Defined as Modified Miyata grade 0, <25mv/mm2 over 3 years (n=138), and over 9 years (n=20), respectively.

‡‡ In vitro comparison with enVista^ MX60, TECNIS^ 1-Piece, and Vivinex^ XY-1 for axial displacement (n=5 IOLs per group, +20.0 D). Axial displacement was measured in vitro in deionized water at 35° C and was measured at multiple compression diameters (11.0, 10.5, 10.0, 9.5, and 9.0 mm). Games-Howell pairwise comparison (10 per IOL) (p=<0.005 for Clareon CNA0T0 versus enVista^ MX60, TECNIS^ ZCB00, or Vivinex^ iSert XY-1 at all compressions)

§§ Clareon® and AcrySof® share the same -0.2um aspheric design resulting in improved depth of focus.

^ Trademarks are the property of their respective owners. 

IMPORTANT PRODUCT INFORMATION – CLAREON® ASPHERIC FAMILY OF HYDROPHOBIC ACRYLIC IOLS WITH THE AUTONOME® AUTOMATED PRE-LOADED DELIVERY SYSTEM 

CAUTION: Restricted by law to sale by or on the order of a physician.

 

INDICATIONS:The Clareon® Aspheric Hydrophobic Acrylic IOLs include the Clareon® Aspheric and Clareon® Aspheric Toric IOLs and are indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. In addition, the Clareon® Aspheric Toric IOL is indicated to correct pre-existing corneal astigmatism.


WARNINGS / PRECAUTIONS: The Clareon® IOL is intended for implantation in the capsular bag only. Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: Patients in whom the posterior capsule is ruptured, zonules are damaged, or primary posterior capsulotomy is planned. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting the IOL in a patient with any of the conditions described in the Directions for Use. For the Clareon® Aspheric Toric IOLs, rotation can reduce astigmatic correction; if necessary, lens repositioning should occur as early as possible prior to lens encapsulation. As with any surgical procedure, there is risk involved. Potential complications accompanying cataract and/or IOL implantation surgery may include, but are not limited to, the following: lens epithelial cell on- growth, corneal endothelial cell damage, infection (endophthalmitis), toxic anterior segment syndrome (TASS), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, anterior uveitis, hyphema, pigment dispersion, posterior capsule opacification, transient or persistent glaucoma, and secondary surgical interventions. 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. Prior to surgery, prospective patients should be informed of the possible risks and benefits associated with this IOL as well as the risks and benefits associated with cataract surgery. After surgery, physicians should provide an implant card to patients regarding the IOL implanted.

 

DO NOT re-sterilize the Clareon® IOL or the AutonoMe® Delivery System by any method. The device is for single use only.

 

ATTENTION: Reference the Directions for Use labeling for each IOL for a complete listing of indications, warnings and precautions.

REFERENCES:

 

  1. Clareon® Aspheric Hydrophobic Acrylic IOL with the AutonoMe® Product information DFU.
  2. Mastropasqua L, Toto L, D'Ugo E, et al. In vivo and in vitro results of an automated preloaded delivery system for IOL implantation in cataract surgery. Int Ophthalmol. 2020;40(1):125-134.
  3. Werner L, Thatthamla I, Ong M, et al. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL in comparison to commercially available IOLs. J Cataract Refract Surg.2019;45(10):1490-1497.
  4. Alcon Data on File, 2017.
  5. Alcon Data on File, 2017.
  6. Oshika T, Fujita Y, Inamura M, Miyata K. Mid-term and long-term clinical assessments of a new 1-piece hydrophobic acrylic IOL with hydroxyethyl methacrylate. J Cataract Refract Surg. 2020;46(5):682-687.
  7. Alcon Data on File, 2020.
  8. Stanojcic N, OʼBrart D, Hull C, et al. Visual and refractive outcomes and glistenings occurrence after implantation of 2 hydrophobic acrylic aspheric monofocal IOLs. J Cataract Refract Surg. 2020;46(7):986-994.
  9. Maxwell A, Suryakumar R. Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study. Clin Ophthalmol. 2018;12:2031-2037.
  10. Das KK, Werner L, Collins S, Hong X. In vitro and schematic model eye assessment of glare or positive dysphotopsia-type photic phenomena: Comparison of a new material IOL to other monofocal IOLs. J Cataract Refract Surg. 2019;45(2):219-227.
  11. Alcon Data on File, 2016.
  12. Von Tress M, Marotta JS, Lane SS, Sarangapani R. A meta-analysis of Nd:YAG capsulotomy rates for two hydrophobic intraocular lens materials. Clin Ophthalmol. 2018;12:1125-1136.
  13. Alcon Data on File, 2017.
  14. Lane S, Collins S, Das KK, et al. Evaluation of intraocular lens mechanical stability. J Cataract Refract Surg. 2019;45(4):501-506.
  15. Alcon Data on File, 2017.
  16. Clareon® IOL Directions for Use.
  17. Alcon Data on File, 2015.

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