Definition: Artificial Iris Is Intended To Be Implanted To Replace The Natural Iris Of The Eye.
| Device Type ID | 4454 |
| Device Name | Artificial Iris |
| Physical State | An Artificial Iris Is Manufactured From A Polymeric Material And May Contain Color Additives To Mimic The Appearance Of The Natural Iris. |
| Technical Method | The Artificial Iris Reduces The Light Sensitivity And/or Glare Associated With Aniridia Through The Artificial Pupil At The Center Of The Prosthesis. The Artificial Iris Does Not Include Optical Power For The Correction Of Refractive Errors. |
| Target Area | Eye |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Intraocular And Corneal Implants Devices Branch (ICIB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | QBT |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4454 |
| Device | Artificial Iris |
| Product Code | QBT |
| FDA Device Classification | Class 3 Medical Device |