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
