The CUSTOMFLEX® ARTIFICIALIRIS is the world’s unique and foldable iris prosthesis, for both medical and aesthetic reconstruction of eyes with complete or partial aniridia.
- Individually custom-made to mimic the original appearance of the patient´s iris
- Injectable
- Versatile
- Controlled light entry: fixed pupil aperture and opaque material
- Biocompatible
The artificial iris CUSTOMFLEX® ARTIFICIALIRIS from HumanOptics AG has received FDA approval.
IMPORTANT NOTE:
The CUSTOMFLEX® ARTIFICIALIRIS is not intended for a cosmetic change of eye color. The CUSTOMFLEX®ARTIFICIALIRIS is developed for implantation in the posterior chamber of the eye and is not suitable for placement in the anterior chamber. It is strongly recommended that the CUSTOMFLEX® ARTIFICIALIRIS be implanted only after removal of the natural lens and IOL.
Technical Information
| Model description | CUSTOMFLEX® ARTIFICIALIRIS with Fiber |
| Application | For aniridia cases where suturing is indicated |
| Material | Pigmented silicone elastomer with polymer fiber meshwork |
| Diameter | Total diameter: 12.8 mm Pupil diameter: 3.35 mm |
| Specifics | The design is based on the labeled photo printout (hard copy) serving as color target for the individual production and resembling the natural iris. The diameter of the implant can be individually trephined. |
| Availability | The delivery time is 4 to 8 weeks after receipt of the order and approved photos. |
| Model description | CUSTOMFLEX® ARTIFICIALIRIS Fiber Free |
| Application | For aniridia cases where suturing is not indicated |
| Material | Pigmented silicone elastomer without polymer fiber meshwork |
| Diameter | Total diameter: 12.8 mm Pupil diameter: 3.35 mm |
| Specifics | The design is based on the labeled photo printout (hard copy) serving as color target for the individual production and resembling the natural iris. The diameter of the implant can be individually trephined. |
| Availability | The delivery time is 4 to 8 weeks after receipt of the order and approved photos. |
ARTIFICIALIRIS – Good Vision Despite an Iris Defect!
The natural iris plays an important role in the optical system of the eye and also gives our eyes their color and influences our personal appearance. Aniridia therefore not only reduces optical quality due to photophobia, aberration errors, glare, and the loss of depth of field, but it also has a negative effect on the appearance and thus on the quality of life of the patient.
Complete or partial aniridia may be congenital, or caused by trauma or illness.
Treatment of aniridia is a challenge in each individual case, in which iris reconstruction using a prosthetic implant is often the only adequate treatment option. HumanOptics (formerly Dr. Schmidt Intraocularlinsen) has developed the ARTIFICIALIRIS in cooperation with Prof. H.-R. Koch (Bonn) to treat aniridia successfully.
Why ARTIFICIALIRIS?
Correction of ocular problems and aesthetic rehabilitation with the CUSTOMFLEX ® ARTIFICIALIRIS results in very high patient satisfaction.
Patient with complete aniridia in the right eye
Same patient after implantation of the ARTIFICIALIRIS
Advantages
| Cosmetic rehabilitation | Individually custom-made implant to mimic the original appearance of the patient’s iris. |
| Injectable | Flexible material that can be folded or rolled for insertion through small incisions. |
| Versatility | For implantation into the sulcus ciliaris or the capsular bag. Can be easily adapted in size and shape to the corresponding iris defect. Combinable with most IOL models. |
| Controlled light entry | Improves contrast sensitivity, reduces photopic phenomena such as glare and light sensitivity, and eliminates transillumination defects through a fixed 3.35 mm aperture and an opaque black back surface that completely absorbs light. |
| Biocompatibility | High quality, highly biocompatible silicone material that has been clinically proven for two decades. |