21 CFR 886.3600 — Intraocular Lens
Ophthalmic (OP) · Part 886 Subpart D—Prosthetic Devices · § 886.3600
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.
Classification Rationale
Class III.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HQL | Intraocular Lens | 3 | 65 | Implant |
| MFK | Lens, Multifocal Intraocular | 3 | 5 | Implant |
| MJP | Lens, Intraocular, Toric Optics | 3 | 0 | Implant |
| NAA | Lens, Intraocular, Accommodative | 3 | 1 | Implant |
| NIZ | Lens, Iris Reconstruction | 3 | 0 | Implant |
| POE | Extended Depth Of Focus Intraocular Lens | 3 | 1 | Implant |
| PZK | Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) | 3 | 1 | Implant |
| QCB | Phakic Toric Intraocular Lens | 3 | 0 | Implant |
