Customflex Artificialiris - Medical Device

INDICATIONS
The CUSTOMFLEX® ARTIFICIALIRIS is intended for use as an iris prosthesis for the treatment of iris defects. The CUSTOMFLEX® ARTIFICIALIRIS is indicated for use in children and adults for the treatment of full or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with full or partial aniridia.

CUSTOM-COLOR MATCH
Every CUSTOMFLEX® ARTIFICIALIRIS is custom-made to match the patient's natural iris tissue, addressing both symptomatic and cosmetic aspects of iris defects.

• Biocompatibility: Long, safe history of highly biocompatible medical-grade silicone
• Flexibility: Flexible material that can be folded for insertion through small incisions using forceps or an auto injector
• Versatility:
• Sutureless and Sutured Surgical Procedures:
• Capsular bag placement
• Passive sulcus fixation with or without sutures
• Suture fixation to the scleral wall
• PCIOL Sutured Ex vivo to the CUSTOMFLEX® ARTIFICIALIRIS
• Can be easily sized for each patient’s needs
• Can be implanted with most intraocular lenses
• Limits Light Transmission: Reduces photosensitivity symptoms and can be used to treat transillumination defects with a fixed aperture of 3.35mm and opaque black posterior surface to absorb light
• Customized: Every CUSTOMFLEX® ARTIFICIALIRIS is custom-made to match the patient’s natural iris tissue, addressing both symptomatic and cosmetic aspects of iris defects.

• Overall Diameter: 12.8 mm
• Pupil Size: 3.35 mm
• Injectable

The safety and efficacy of the CUSTOMFLEX® ARTIFICIALIRIS was demonstrated in a non-randomized clinical trial of 447 eyes of 389 adult and pediatric patients with aniridia or other iris defects. There was an overall significant improvement in photosensitivity symptoms, quality of life, and vision in pediatric and adult subjects. At study conclusion, 63% of eyes reported no or mild daytime light sensitivity; and, 79% reported no or mild nighttime light sensitivity, while more than 70% of eyes reported no or mild glare during the day or at night. 94% of subjects were satisfied with the CUSTOMFLEX® ARTIFICIALIRIS appearance.