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