Customflex Artificial Iris

Introducing the

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

qReduction in visual acuity

qIncrease in light sensitivity (Photophobia)

qDriving at night, reading difficulty, as well as glare, halos, and starbursts

qIncrease in the pressure of the eye (Glaucoma)

qClouding of the lens (Cataract)

CUSTOMFLEX® ARTIFICIALIRIS

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

qSurgically implanted device used to treat aniridia and other iris defects in adults and children

qAniridia is a condition in which the iris is damaged or absent

qThe CUSTOMFLEX® ARTIFICIALIRIS received FDA approval on May 30, 2018

qThe CUSTOMFLEX® ARTIFICIALIRIS was granted Breakthrough Device designation

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

qNon-randomized U.S. Clinical Trial Results

q447 eyes of 389 adult and pediatric patients with aniridia and other iris defects

qMore than 70% of patients reported:

qSignificant decreases in light sensitivity and glare

qAn improvement in health-related quality of life

q94% of patients were satisfied with the CUSTOMFLEX® ARTIFICIALIRIS appearance.

CUSTOMFLEX® ARTIFICIALIRIS

Biocompatible, foldable and versatile

qCustom-made for each individual patient

qBiocompatible medical-grade silicone material*

q12.8 mm in diameter and can be sized by trephining to fit within the ciliary sulcus or capsular bag

qCan be combined with most IOLs

qThe anterior surface mimics the natural iris by its:

qColor composition (embedded non-toxic pigments

qIris 3D structure

qBlack 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