C-flex®

C-flex®

Built on the proven Rayner Primary IOL Platform, the C-flex  is a hydrophilic acrylic monofocal IOLs with 360° enhanced square edge.

C-flex  is the 5.75mm diameter monofocal optic, manufactured in powers from +8.0 to +30.0 D and can be delivered through a 2.2mm wound assisted clear corneal incision.

 

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

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

 

Designed with Rayner’s Anti-Vaulting Haptic (AVH) Technology®. Our C-flex  IOL provides proven rotational and centrational stability, and excellent fixation in the capsular bag1

  • Superb centration
  • - Maximum offset of only 1 mm 3 months after surgery2
  • Excellent rotational and torsional stability
  • - 3.1° mean IOL rotation 3 months after surgery2

Reducing dysphotopsia by design12

 
  • Rayner’s Enhanced Square Edge Technology shows no general increase in glare from previous models without a square edge7
  • The low refractive index (1.46) of Rayacryl®

360° Optimised Barrier to reduce PCO – Low Nd: YAG capsulotomy rates

 
  • Rayner’s 360° Amon-Apple Enhanced Square Edge creates an optimum barrier to reduce epithelial cell migration including at the haptic-optic junction 7,5
ND:YAG CAPSULOTOMY RATES7 MEAN TIME TO ND:YAG CAPSULOTOMY7
At 12 months 0.6% 9.3 ± 5.5 months (range 2.6 - 22.7 months)
Follow-up period: 5.3 – 29 months
At 24 months 1.7%

Study of 3,461 patients receiving Rayner 570C IOLs over a 24 month period, Nd:YAG capsulotomy rates were extremely low and comparable with hydrophobic acrylic lenses with square-edge optics7

Vacuole free material for a glistening free IOL

 
  • Single piece IOL created from Rayacryl® an homogeneous material free of microvacuoles, resulting in a glistening free IOL8
  • Compressible material for delivery through a micro incision
  • Excellent handling characteristics with controlled unfolding within the capsular bag
  • Low silicone oil adherence9
  • Excellent uveal biocompatibility13
  • Hydrophilic acrylic material with low inflammatory response10

References:

 
  1. Claoué C. Clinical and Surgical Ophthalmology 2008; 26(6): 198-200
  2. Alberdi R et al. J Refract Surg. 2012; 28(10):696-700
  3. Nanavaty MA et al. J Cataract Refract Surg. 2009; 35:663–671
  4. Yagci R et al. Eur J Ophthalmol. 2014 Jul 24; 24(5):688-92
  5. Vyas AV et al. J Cataract Refract Surg 2007; 33:81-87
  6. Johansson B et al. J Cataract Refract Surg. 2007; 33:1565–1572
  7. Mathew RG and Coombes AGA. Ophthalmic Surg Lasers Imaging. 2010 Nov-Dec; 41(6):651-5
  8. Rayner. Data on File. White paper
  9. McLoone E et al. Br J Ophthalmol. 2001; 85:543–545
  10. Richter-Mueksch S et al. J Cataract Refract Surg. 2007; 33:1414–1418
  11. Altmann GE et al. J Cataract Refract Surg. 2005; 31(3): 574-585
  12. Cezón Prieto J and Bautista MJ. J Cataract Refract Surg. 2010; 36:1508-1516
  13. Tomlins PJ et al. J Cataract Refract Surg. 2014; 40:618–625
  14. Pepose JS et al. Graefes Arch Clin Exp Ophthalmol. 2009 Jul;247(7):965-73
C-flex IOLs are supplied with a Rayner injector
  • 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.
Model Name: C-flex
Model Number: 570C
Power Range:

+8.0 D to +30.0 D (0.5 D increments)

Optic Diameter: 5.75 mm
Haptic Diamter: 12.00 mm
Delivery System
Injector Type: Sterile Single use loadable injector
Nozzle Size: 1.8 mm
Bevel Angle: 35°
Lens Delivery: Single handed plunger
Monofocal 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
Optic Shape: Biconvex
Optic Edge Design: Amon-Apple 360° enhanced square edge
Haptic Angulation: 0°, uniplaner
Haptic style: Closed loop with anti-vaulting haptic (AVH) technology
Estimated constants for optical biometry SRK/T: 118.6
Estimated constants for Ultrasound A-constant: 118.0

Please note that the constants indicated for all Rayner lenses are estimates and are for guidance purposes only. Surgeons must always expect to personalise their own constants based on initial patient outcomes, with further personalisation as the number of eyes increases.

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.

  • Microphthalmia
  • Active ocular disease (e.g. chronic severe uveitis,proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
  • Children under the age of 21 years
  • Corneal decompensation or corneal endothelial cell insufficiency
  • 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:

  • Recurrent ocular disease (e.g. uveitis, diabetic retinopathy, glaucoma, corneal decompensation)
  • Previous ocular surgery
  • Non-age related cataract
  • Vitreous loss
  • Iris atrophy
  • Severe Aniseikonia
  • Ocular Hemorrhage
  • Macular degeneration
  • Zonular dehiscence
  • Ruptured posterior capsule
  • Patients in whom the intraocular lens may affect the ability toobserve, diagnose, or treat posterior segment diseases.
  • 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).
  • A distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible.
  • Circumstances that would result in damage to the endothelium during implantation.
  • Suspected microbial infection.
  • 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.

C-flex Aspheric

C-flex Spheric