Sulcoflex Toric: Precision for Astigmatism

Rayner Sulcoflex: An elegant solution for treating
refractive surprise.

Rayner Sulcoflex Aspheric Pseudophakic Supplementary IOLs are designed to be implanted in the ciliary sulcus to correct residual post-operative refractive errors following the implantation of a conventional IOL in the capsular bag.

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Sulcoflex Trifocal

An elegant solution for the correction of presbyopia.

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IOL

When considering an intraocular lens, what’s important to you?
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When considering your options to correct refractive surprise, what’s important to you?

- ✓ Ease of use
- ✓ An adjustable solution for peace of mind
- ✓ Efficacy & patient outcomes
- ✓ Low capital expenditure
- ✓ Designed to avoid the potential problems of conventional “piggy-back” IOLs^1,6,9

Over 10 years of success
since receiving CE approval

For when compromise is not an option.

Reduced surgical risk associated with IOL exchange		Predictability		High patient satisfaction
✓	Less surgical trauma than primary IOL exchange	✓	Lack of tilt or decentration	✓	Low complication rate
✓	Avoids sometimes difficult removal of fibrosed, fixated primary implant	✓	Predictable refractive outcomes with high visual acuity	✓	Stable long-term refractive results

“Implantation of the Sulcoflex is safe, easy and it is less traumatic than IOL exchange.¹³“

Michael Amon MD, Professor and Head of the Department of Ophthalmology at the Academic Teaching Hospital of St John, Vienna, Austria

Features and benefits of the Sulcoflex Toric IOL

With the Standard range from –5.0 D to +5.0 D and the Premium range extending from –10.0 D to +10.0 D, Sulcoflex Toric IOLs offer an effective option for the resolution of post-operative myopic or hypermetropic refractive surprises.

Design

Large, 6.5 mm round-edged optic, designed to:

Reduce the risk of pupillary block and photic effects⁴
Reduce risk of optic-iris capture¹
Minimise edge glare and associated dysphotopsia¹

Large 14.0 mm overall length with undulating haptics:

Designed for stable fixation in the ciliary sulcus
Unique undulating round edge haptic design with 10° angulation
Excellent centration stability compared to capsular bag fixated IOLs⁵
Reduced risk of uveal contact and abrasion¹
Reduced Pigment Dispersion Syndrome¹

Optics

Aberration-neutral Aspheric Optics.

Improved contrast sensitivity and functional visual acuity*

Material

Rayacryl material for:

Good uveal Biocompatibility⁷
Superb opticalclarity – no vacuolesor glistenings⁸

Smooth undulating haptics to minimise the risk of adverse tissue reaction in the sulcus.²
Posterior concave surface to avoid contact with the primary IOL.¹

* When compared to spherical optics

Designed to avoid the potential problems of conventional ‘piggy-back’** IOLs^1,6,9

Unique posterior concave surface, minimises the possibility of interaction with the primary IOL
Reduced likelihood of unwanted photopic effects
Reduced refractive error with hyperopic defocus

Physical contact between the two IOLs minimised.

Iris - Sulcoflex

Sulcoflex - IOL

“I think at the moment, this is just the perfect design.³“

Norbert Körber, FEBO

References:

Amon MI. Correcting refractive surprises following cataract surgery. Cataract Refract Surg Today Europe. 2009:56-9.
Khan, M.I. & Muhtaseb, M. Piggybacking with the Sulcoflex. J Cataract Refract Surg. 2010;36:14-6.
Claoué et al. Sulcoflex Pseudophakic Supplementary IOLs. CRST Euro Supple. 2009.
Amon MI et al. Enhancing pseudophakic vision with the Rayner Sulcoflex lens. ESCRS Euro Times Supple. 2012:2-3.
Prager F et al. Capsular bag-fixated and ciliary sulcus-fixated intraocular lens centration after supplementary intraocular lens implantation in the same eye. J Cataract Refract Surg. 2017;43(5):643-647.
Kahraman G, Amon M, Vienna, Austria. New Supplementary intraocular lens for refractive enhancement in pseudophakic patients. J Cataract Refract Surg. 2010 Jul;36(7):1090-4.
Tomlins PJ et al. Long-term biocompatibility and visual outcomes of a hydrophilic acrylic intraocular lens in patients with uveitis. J Cataract Refract Surg. 2014; 40:618- 625.
Rayner data on file.
Manzouri B et al. Supplementary IOLs: Monofocal and Multifocal, Their Applications and Limitations. Asia- Pacific Journal of Ophthalmology. Vol 6, Number 4, July/ August 2017.
Sulcoflex a new IOL-concept for the pseudophakic eye [Press release]. September 2007.

Injector

Sulcoflex IOLs are compatible with the Medicel Accuject 1.8
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Sulcoflex Aspheric Toric: Delivery

Uniquely designed loading bay with an extension “lip” to facilitate loading.
Soft plunger tip completely fills the nozzle and offers a soft protective interface with the IOL.
Syringe-style design for single-handed technique for smooth IOL delivery with predictable and efficient insertion, ensuring consistent IOL implantations.
Sterile single use, ready to use.

Technical spec.

Sulcoflex Toric
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SulcoflexToric technical spec.

Model Name	Sulcoflex Toric
Model Number	IOL710T
Power Range	Spherical Equivalent: -7.0 to +7.0 D (0.5 D sphere increments) Cylinders: +1.0 to +6.0 D (0.5 D sphere increments)

Aspheric Trifocal IOL
Material	Single piece Rayacryl hydrophilic acrylic
Water Content	26 % in equilibrium
UV Protection	Benzophenone UV absorbing agent
UV Light Transmission	UV 10 % cut-off is 380 nm
Refractive Index	1.46
ABBE	56
Overall Diameter	14.00 mm
Optic Diameter	6.50 mm
Optic Shape	Anterior convex, posterior concave toric
Haptic Angulation	10° Posterior angulation
Haptic Style	Undulating and rounded C-loop haptics
Estimated Constant for Power Calculation	Expected lens position = 4.5 mm

Regulatory

Information
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Sulcoflex Toric regulatory

Not all products or offerings are approved or offered in every market and approved labelling and instructions may vary from one country to another. For country specific product information contact your local distributor or email enquires@rayner.com.

This product is not approved by the FDA for use or distribution in the United States of America.

Rayner hold a selection of EC certificates for various products. Please contact the Regulatory Affairs team for the current version.

Clinical papers

Download and review
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Sulcoflex Aspheric peer review papers

Yagci R, Uzun F, Acer S, Hepsen IF. Comparison of visual quality between aspheric and spherical IOLs. Eur J Ophthalmol. 2014 Sep-Oct;24(5):688-92
Mathew RG. & Coombes AG. Reduction of Nd:YAGCapsulotomy Rates After Implantation of a Single-Piece Acrylic Hydrophilic Intraocular Lens With 360° Squared Optic Edge: 24-Month Results . Ophthalmic Surg Lasers Imaging. 2010 Nov-Dec;41(6):651-5
Vyas AV, Narendran R, Bacon PJ, & Apple DJ. Three-hundred-sixty degree barrier effect of a square-edged and an enhanced-edge intraocular lens on centripetal lens epithelial cell migration Two-year results. J Cataract Refract Surg. 2007 Jan;33(1):81-7
Werner L, Mamalis N, Pandey SK, Izak AM, Nilson CD, Davis BL, Weight C, Apple DJ. Posterior capsule opacification in rabbit eyes implanted with hydrophilic acrylic intraocular lenses with enhanced square edge. J Cataract Refract Surg. 2004 Nov;30(11):2403-9
Tandogan T, Auffarth GU, Choi CY, Liebing S, Mayer C, Khoramnia R. In vitro comparative optical bench analysis of a spherical and aspheric optic design of the same IOL model. BMC Ophthalmol. 2017 Feb 8;17(1):9.
Nanavaty MA. & Kubrak-Kisza M. Evaluation of preloaded intraocular lens injection systems: Ex vivo study. J Cataract Refract Surg. 2017 Apr;43(4):558-563.

Videos

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Sulcoflex Toric videos

Marketing materials

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Sulcoflex Toric marketing materials

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