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C-flex® Aspheric Monofocal

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Built on the proven Rayner Primary IOL Platform, the C-flex Aspheric is a hydrophilic acrylic aspheric monofocal IOLs with 360° enhanced square edge and true, aberration-neutral optic technology. We believe that every patient’s vision is important and there is no such thing as the “average” cornea. That’s why the Rayner C-flex Aspheric lens is aberration neutral, allowing patients to benefit from the natural residual positive aberration of the cornea.

C-flex Aspheric 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.

Detailed Product Information

C-flex Aspheric Patient Benefits

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


Spherical IOL

Spherical IOL
Power increases from centre to edge.
 

Disadvantages

  • Adds to corneal positive spherical aberration (SA)
  • Degrades image quality and contrast sensitivity


Aberration-neutral aspheric 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.

 

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


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 Simulation of retained depth of field   

 

 Simulation of reduced depth of field

 

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

 

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  * Of those patients who expressed a preference

References:
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. Johansson B et al. J Cataract Refract Surg. 2007; 33:1565–1572
12. Pepose JS et al. Graefes Arch Clin Exp Ophthalmol. 2009 Jul;247(7):965-73
13. Altmann GE et al. J Cataract Refract Surg 2005; 31:574-585

C-flex Aspheric Technical Specification

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

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

**The A-constant indicated for all Rayner lenses are estimates and are for guidance purposes 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 for the most up to date and accurate starting point estimate.

C-flex Aspheric Presentation

 

 

Product Name

Model No.

Presentation

Power Range

Increments

C-flex Aspheric – USA ONLY

C-flex Aspheric – USA ONLY

970C

Stand alone Lens Carton

+8.0 to +30.0 D

0.5 D

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

C-flex Aspheric Regulatory, Cautions and Indications

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 toobserve, 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.

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