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 |
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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 |