Definition: An Iris Reconstruction Lens Is An Intraocular Lens (IOL) Which Is Used In Patients With Partial Or Complete Loss Of The Iris Induced By Trauma Or Congenital Defect. The IOL Serves As An Artificial Iris And Lens, Reducing Light Sensitivity And/or Glar
| Device Type ID | 4378 |
| Device Name | Lens, Iris Reconstruction |
| Regulation Description | Intraocular Lens. |
| Regulation Medical Specialty | Ophthalmic |
| 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 |
| CFR Regulation Number | 886.3600 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NIZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 4378 |
| Device | Lens, Iris Reconstruction |
| Product Code | NIZ |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Intraocular Lens. |
| CFR Regulation Number | 886.3600 [🔎] |