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- Diagnostic DevicesCFR Sub-Part
- General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Prosthetic DevicesCFR Sub-Part
- HPZImplant, Eye Sphere2Product Code
- HQHEye, Artificial, Non-Custom1Product Code
- HQJImplant, Absorbable, (Scleral Buckling Methods)2Product Code
- HQLIntraocular Lens3Product Code
- HQMKeratoprosthesis, Permanent Implant2Product Code
- HQNConformer, Ophthalmic2Product Code
- HQTShell, Scleral2Product Code
- HQWClip, Tantalum, Ophthalmic2Product Code
- HQXImplant, Orbital, Extra-Ocular2Product Code
- KYFImplant, Eye Valve2Product Code
- MFKLens, Multifocal Intraocular3Product Code
- MJPLens, Intraocular, Toric Optics3Product Code
- MLPKeratoprosthesis, Temporary Implant, Surgical Use2Product Code
- MQUOcular Peg2Product Code
- MTZWrap, Implant, Orbital2Product Code
- NAALens, Intraocular, Accommodative3Product Code
- NCKButton, Iris, Eye, Artificial1Product Code
- NFMExpander, Tissue, Orbital2Product Code
- NIZLens, Iris Reconstruction3Product Code
- NQBConformer, Ophthalmic, Biological Tissue2Product Code
- NXMProsthesis, Eyelid Spacer/Graft, Biologic2Product Code
- POEExtended Depth Of Focus Intraocular Lens3Product Code
- PUFOcular Peg, Exempt2Product Code
- PZKLight Adjustable Lens (Lal) And Light Delivery Device (Ldd)3Product Code
- QCBPhakic Toric Intraocular Lens3Product Code
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
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Phakic Toric Intraocular Lens
- Page Type
- Product Code
- Definition
- Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline 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 Medical Specialty
- Ophthalmic
- Review Panel
- Ophthalmic
- Submission Type
- PMA
- Device Classification
- Class 3
- Regulation Number
- 886.3600
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- Yes
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
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CFR § 886.3600 Intraocular lens
§ 886.3600 Intraocular lens.
(a) Identification. An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 886.3.