Mid Atlantic Cornea Consultants
Sudeep Pramanik, M.D., M.B.A., F.A.C.S.

Customflex Artificial Iris

CUSTOMFLEX® ARTIFICIALIRIS   

For Complete or Partial Aniridia.


Aniridia is an eye disorder characterized by a complete or partial absence of the iris.  It can be congenital or acquired.

 

Aniridia is not just a cosmetic condition

 

  • Reduction in visual acuity
  • Increase in light sensitivity (Photophobia)
  • Driving at night, reading difficulty, as well as glare, halos, and starbursts
  • Increase in the pressure of the eye (Glaucoma)
  • Clouding of the lens (Cataract)

 

 



CUSTOMFLEX® ARTIFICIALIRIS

 

The First Iris Prosthesis Approved for Use in the U.S.

 

  • Surgically implanted device used to treat aniridia and other iris defects in adults and children
  • Aniridia is a condition in which the iris is damaged or absent
  • The CUSTOMFLEX® ARTIFICIALIRIS received FDA approval on May 30, 2018
  • The CUSTOMFLEX® ARTIFICIALIRIS was granted Breakthrough Device designation

  

 

 

Overall Improvement in Photosensitivity Symptoms, Quality of Life, and Vision in Pediatric and Adult Subjects

  • Non-randomized U.S. Clinical Trial Results
  • 447 eyes of 389 adult and pediatric patients with aniridia and other iris defects
  • More than 70% of patients reported:
  • Significant decreases in light sensitivity and glare
  • An improvement in health-related quality of life
  • 94% of patients were satisfied with the CUSTOMFLEX® ARTIFICIALIRIS appearance.

 

 

 

 

CUSTOMFLEX® ARTIFICIALIRIS       

Biocompatible, foldable and versatile


 

  • Custom-made for each individual patient
  • Biocompatible medical-grade silicone material*
  • 12.8 mm in diameter and can be sized by trephining to fit within the ciliary sulcus or capsular bag
  • Can be combined with most IOLs
  • The anterior surface mimics the natural iris by its:
  • Color composition (embedded non-toxic pigments
  • Iris 3D structure
  • Black posterior surface to prevent light transmission

 

 

CUSTOMFLEX® ARTIFICIALIRIS

Custom Made for Each Patient

 

CUSTOMFLEX® ARTIFICIALIRIS

A Game Changer

New hope for patients with aniridia or other iris defects

 

  • Regulated light transmission diminishes visual symptoms associated with aniridia
  • Customized implant replicates the natural appearance of each patient’s eye
  • The safety and efficacy of the CUSTOMFLEX® ARTIFICIALIRIS was demonstrated in a non-randomized clinical trial

 

 

  


 

Testimonials

Incredible! The staff and doctors are just beyond brilliant. Kind, friendly, patient, informative. I couldn't ask for better and I don't think better exists. Absolutely would recommend to everyone without hesitation. Thank you all for everything.

Lucy H. | May, 2024

5 year update.
As a former -10 diopter glasses-wearer, the team here gave me the freedom live life. No more nagging concerns of 'Do I have enough contacts?' or 'How will I wear my glasses while doing _________?'. Going through my 20s without glasses is amazing!
Thank you for the ICL surgery! I am grateful every single day.

Allison M. | February, 2024

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