POE · Extended Depth Of Focus Intraocular Lens
Ophthalmic · 21 CFR 886.3600 · Class 3
Overview
| Product Code | POE |
|---|---|
| Device Name | Extended Depth Of Focus Intraocular Lens |
| Regulation | 21 CFR 886.3600 |
| Device Class | Class 3 |
| Review Panel | Ophthalmic |
| Implant | Yes |
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P210005 | IC-8 Apthera Intraocular Lens (IOL) | Acu Focus, Inc. | Jul 22, 2022 | APPR |
| P930014S126 | AcrySof IQ Vivity Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A | Alcon Laboratories, Inc. | Feb 26, 2020 | APPR |
| P980040S065 | TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS | Johnson & Johnson Surgical Vision, Inc. | Jul 15, 2016 | APPR |
Top Applicants
- Acu Focus, Inc. — 1 clearance
- Alcon Laboratories, Inc. — 1 clearance
- Johnson & Johnson Surgical Vision, Inc. — 1 clearance
