Phakic Toric Intraocular Lens

Device Code: 4417

Product Code(s): QCB

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 Classification Information

Device Type ID4417
Device NamePhakic Toric Intraocular Lens
Physical StateThe 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 MethodThe 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 AreaThe 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 DescriptionIntraocular Lens.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
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 TypePMA
CFR Regulation Number886.3600 [🔎]
FDA Device ClassificationClass 3 Medical Device
Product CodeQCB
GMP ExemptNo
Summary MRIneligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4417
DevicePhakic Toric Intraocular Lens
Product CodeQCB
FDA Device ClassificationClass 3 Medical Device
Regulation DescriptionIntraocular Lens.
CFR Regulation Number886.3600 [🔎]
Device Problems
Inadequacy Of Device Shape And/or Size
3
Unintended Movement
1
Device Dislodged Or Dislocated
1
Total Device Problems 5
TPLC Last Update: 2019-04-02 20:48:42

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