21 CFR 886.4275 — Fluid, Intraocular
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4275
Identification
An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
Classification Rationale
Class III.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LWL | Fluid, Intraocular | 3 | 5 | |
| LZP | Aid, Surgical, Viscoelastic | 3 | 13 |
