US Product PortfolioC-flex® Aspheric IOL

Your skill. Our vision.

Reliable refractive outcomes and a low rate of post-operative complications

Rayner’s Anti-Vaulting Haptic (AVH) Technology provides

• Excellent refractive outcomes1

• Stable centration2

Reducing dysphotopsia by design14 • Rayner’s Enhanced Square Edge Technology shows

no general increase in glare from previous models7

• The low refractive index (1.46) of Rayacryl®

Optimal visual quality in all lighting conditions

• Aspheric optic technology reduces higher order aberrations when compared with spherical IOLs3,4

• Excellent contrast sensitivity3,4 and a retained depth of field from aberration-neutral aspheric optic

When considering an intraocular lens, what’s important to you?

Rayner IOL Platform

Low Nd: YAG capsulotomy rates

Rayner’s 360° Amon-Apple Enhanced Square Edge creates an optimum

barrier to reduce epithelial cell migration including the haptic-optic junction 6,15

An IOL free from vacuoles and glistenings7

• Single piece IOLs created from Rayacryl® an homogeneous material free of microvacuoles, resulting in a glistening free IOL • Compressible material for delivery through a small incision • Excellent handling characteristics with controlled unfolding within the capsular bag • Low silicone oil adherence8

• Excellent uveal biocompatibility9 • Hydrophilic acrylic material with low inflammatory response10

ND:YAG CAPSULOTOMY RATES6 MEAN TIME TO ND:YAG CAPSULOTOMY6

At 12 months 0.6% 9.3 ± 5.5 months

(range 2.6 - 22.7 months)

Follow-up period: 5.3 – 29 monthsAt 24 months 1.7%

Study of 3,461 patients receiving Rayner C-flex 570C IOLs over a 24 month period, Nd:YAG capsulotomy rates were

extremely low.6

Patients deserve optimal visual quality and functional visual acuity in all light conditions

Studies have demonstrated that abberration-neutral technology:

• Offers improved contrast sensitivity compared with spherical IOLs3,4

• Provides better low light level visual acuity than spherical IOLs12

• Can offer more depth of field than aberration-negative IOLs by retention of the patient’s natural level of corneal spherical aberration5

• Are less susceptible to the effects of decentration than aberration-negative IOLs13

C-flex® Aspheric

Spherical IOL

Aberration-neutral aspheric IOL

Prolate anterior surface means uniform power from centre to edge. Aberration-neutral optic retains natural residual positive SA of the cornea.

Power increases from centre to edge.

0

Disadvantages

Adds to corneal positive spherical aberration (SA)

Degrades image quality and contrast sensitivity

Advantages

High quality vision in all lighting conditions

Good contrast sensitivity

More depth of field than an aberration-negative aspheric IOL

Optimal results for ALL patients; not just for the “average” cornea

Why is it important to retain depth of field?

Patients prefer a lens that retains depth of field5

• Retention of some positive SA can provide a level of pseudo-accommodation, offering preferable visual outcomes5

– In a clinical trial of 80 patients where an aberration-neutral lens was implanted in one eye and an aberration-negative lens was implanted in the other eye:5

* Of those patients who expressed a preference

C-flex Aspheric Power Ranges

MODEL NAME MODEL NUMBER

POWER RANGE INCREMENTS OPTIC DIAMETER

OVERALL LENGTH

ESTIMATED SRK-T A-CONSTANT** (NON-CONTACT BIOMETRY)

C-flex Aspheric 970C +8.0 to +30.0 D 0.5 D 5.75mm 12.00mm 118.6

** The A-constant indicated for all Rayner lenses are estimates and are for guidance only. Surgeons must always expect to personalise their

own A-constants based on initial patient outcomes, with further personalisation as the number of eyes increases. We strongly recommend that

surgeons consult the ULIB website (http://www.augenklinik.uni-wuerzburg.de/ulib/).

2 x as many patients* preferred the aberration-neutral IOL

3 x fewer reports of visual disturbances with

the aberration-neutral IOL

Simulation of retained depth of field Simulation of reduced depth of field

C-flex is also available in a spherical version. Please contact your Rayner sales specialist for further information.

Smooth IOL delivery with predictable and efficient insertion ensuring consistant IOL implantations.

Syringe-Style, Single-Handed Technique

Mini Incision IOL Injection System for C-flex® Aspheric

RaySert® PLUS

Ready to use. RaySert PLUS is supplied sterile in an individual pack.

Sterile Single-Use

Wound assisted implantation through a 2.2mm mini incision, reducing surgical induced astigmatism.

Small Diameter Tip

Loading Instructions

Fully retract the plunger ensuring that the soft tip does not protrude into the loading bay.

Position the lens centrally in the loading bay in a “reverse - S” configuration.

Hold open the flap and press down on lens with closed forceps to ensure that the edges of the optic and haptics are completely secured under the edge (lip) of the flaps.

Visually observe that the lens is symmetrically folded within the loading bay.

Advance the plunger in a slow controlled manner. Anticipate an initial slight but not excessive resistance, which could indicate a trapped lens. Observe that the lens remains symmetrically folded within the nozzle.

While keeping the lens in position with open forceps, gently close the flaps of the injector ensuring that no parts of the optic or haptics are trapped before locking the flaps firmly together.

Open the loading bay flap fully to 90° and apply a suitable commercially available viscoelastic inside the nozzle and to both grooves of the loading bay.

Carefully peel back the foil lid of the lens blister. Gently lift out the lens using parallel tipped, non-serrated forceps.

Once the lens exits the nozzle, stop depressing the plunger.

01

04

07

02

05

08

03

06

09

Rayner C-flex® Intraocular Lenses (IOLs)

CAUTION: Federal U.S law restricts this device to the sale by, or on the order of a physician.

INDICATIONS: Rayner C-flex® intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsification. The lens is intended to be placed in the capsular bag.

CONTRAINDICATIONS: Apart from non-specific contraindications related to any form of ocular surgery, the following specific contraindications must be respected.

1. Microphthalmia 2. Active ocular disease (e.g. chronic severe uveitis,

proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)

3. Children under the age of 21 years 4. Corneal decompensation or corneal endothelial cell

insufficiency 5. Persons who are pregnant or nursing.

WARNINGS: A risk/benefit ratio must be assessed before confirming a patient as a candidate for a Rayner C-flex® IOL implantation, if they are suffering from any of the following conditions:

1. Recurrent ocular disease (e.g. uveitis, diabetic retinopathy, glaucoma, corneal decompensation)

2. Previous ocular surgery 3. Non-age related cataract 4. Vitreous loss 5. Iris atrophy 6. Severe Aniseikonia 7. Ocular Hemorrhage 8. Macular degeneration 9. Zonular dehiscence 10. Ruptured posterior capsule 11. Patients in whom the intraocular lens may affect the ability to

observe, diagnose, or treat posterior segment diseases. 12. 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).

13. A distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible.

14. Circumstances that would result in damage to the endothelium during implantation.

15. Suspected microbial infection. 16. Children under the age of 2 years are not suitable

candidates for intraocular lenses.

Since the Rayner 570C C-flex® IOL clinical study was conducted with lens implantations into the capsular bag only, there are insufficient clinical data to demonstrate the safety and efficacy for ciliary sulcus placement.

ATTENTION: Reference the Instructions for Use labelling for a complete listing of Indications and precautions.

Rayner RaySert® PLUS Small Incision Single Use Soft-Tipped Injector

CAUTION: Federal U.S law restricts this device to the sale by, or on the order of a physician.

INDICATIONS: Rayner RaySert® PLUS injector is intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of the injectors in their approved labelling.

CONTRAINDICATIONS: Apart from non-specific contraindications related to any form of ocular surgery, and in addition to the contraindications for the lens model being injected, the following contraindications must be respected:

1. Vitreous in the anterior chamber. 2. Zonular insufficiency.

ATTENTION: Reference the Instructions for Use labelling for a complete listing of Indications and precautions.

For optimal visual quality and reliable outcomes choose the Rayner IOL

C-flex® Aspheric aberration-neutral, monofocal IOL for optimal visual quality in all lighting conditions • Improved contrast sensitivity compared with conventional spherical lenses3,4 • Retain more depth of field than aberration-negative IOLs5 • Less susceptible to the effects of decentration than aberration-negative IOLs13

Global HeadquartersRayner Intraocular Lenses Limited1-2 Sackville Trading Estate Sackville Road, Hove, East SussexBN3 7AN. United Kingdom

Tel: +44 (0) 1273 205 401 Email: iol_enquiries@rayner.com Web: www.rayner.com

US Customer Service6901 Stillwell, Kansas City,MO 64120, USA

Tel: 866-961-1811Fax: 866-956-5029

References:1. Percival SPB et al. Eye 2002 May;16(3):309–3152. Alberdi R et al. J Refract Surg. 2012;28(10):696-7003. Nanavaty MA et al. J Cataract Refract Surg. 2009; 35:663–6714. Yagci R et al. Eur J Ophthalmol. 2014 Jul 24;24(5):688-925. Johansson B et al. J Cataract Refract Surg. 2007; 33:1565–15726. Mathew RG and Coombes AGA. Ophthalmic Surg Lasers Imaging. 2010 Nov-Dec;41(6):651-57. Rayner data on file8. McLoone E et al. Br J Ophthalmol. 2001;85:543–5459. Tomlins PJ et al. J Cataract Refract Surg. 2014; 40:618–62510. Richter-Mueksch S et al. J Cataract Refract Surg. 2007; 33:1414–141811. Erie JC et al. J Cataract Refract Surg. 2001; 27:614–62112. Pepose JS et al. Graefes Arch Clin Exp Ophthalmol. 2009 Jul;247(7):965-7313. Altmann GE et al. J Cataract Refract Surg 2005; 31:574-58514. Vyas A. Clin Exp Ophthalmol 2015, 6(1):39115. Vyas A et al. J. Cataract Refract Surg 2007, 33:81-87

C-flex, Rayacryl, RaySert and AVH Technology are proprietary marks of Rayner Intraocular Lenses.Copyright Rayner Intraocular Lenses Limited 2015. Unauthorized reproduction prohibited.EC-2015-20 03/15