Definition: Intended To Be Implanted Within The Eye To Optically Correct Astigmatism (with Or Without Other Refractive Errors), Without Removing The Natural Crystalline Lens.
| Device Type ID | 4417 |
| Device Name | Phakic Toric Intraocular Lens |
| Physical State | The Device Has A Similar Appearance And Construction To Any Other Intraocular Lens. An Intraocular Lens Is A Device Made Of Materials Such As Glass Or Plastic. |
| Technical Method | The Device Is Implanted Into The Eye Without Removing The Natural Crystalline Lens. It Is Used To Correct Refractive Errors, Specifically Astigmatism (with Or Without Myopia Or Hyperopia). |
| Target Area | The Device Is Implanted Within The Eye Without Removing The Eye's Natural Crystalline Lens. It Can Be Placed Just In Front Of Or Just Behind The Iris. |
| 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 | QCB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4417 |
| Device | Phakic Toric Intraocular Lens |
| Product Code | QCB |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Intraocular Lens. |
| CFR Regulation Number | 886.3600 [🔎] |
| Device Problems | |
|---|---|
Inadequacy Of Device Shape And/or Size | 3 |
Unintended Movement | 1 |
Device Dislodged Or Dislocated | 1 |
| Total Device Problems | 5 |