MFK · Lens, Multifocal Intraocular
Ophthalmic · 21 CFR 886.3600 · Class 3
Overview
| Product Code | MFK |
|---|---|
| Device Name | Lens, Multifocal Intraocular |
| 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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P240005 | enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) | Bausch & Lomb, Inc. | Oct 10, 2024 | APPR |
| P200020 | SBL-3 Multifocal Intraocular Lens | Lenstec, Inc. | Jul 22, 2022 | APPR |
| P980040S124 | TECNIS Synergy Intraocular Lens, TECNIS Synergy Toric II Intraocular Lens, TECNIS Synergy IOL with TECNIS Simplicity Del | Johnson & Johnson Surgical Vision, Inc. | Apr 28, 2021 | APPR |
| P040020S087 | AcrySof IQ PanOptix Trifocal Intraocular Lens and AcrySof IQ PanOptix Toric Trifocal Intraocular Lens | Alcon Research, Ltd. | Aug 26, 2019 | APPR |
| P040020S049 | ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC INTRAOCULAR LENS | Alcon Research, Ltd. | Dec 22, 2016 | APPR |
| P040020S050 | ACRYSOF IQ RESTOR +2.5 D MULTIFOCAL INTRAOCULAR LENS | Alcon Research, Ltd. | Apr 13, 2015 | APPR |
| P980040S049 | TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL) | Johnson & Johnson Surgical Vision, Inc. | Dec 17, 2014 | APPR |
| P080010 | TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | Johnson & Johnson Surgical Vision, Inc. | Jan 16, 2009 | APPR |
| P040020 | ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL | Alcon Research, Ltd. | Mar 21, 2005 | APPR |
| P960028 | AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS | Johnson & Johnson Surgical Vision, Inc. | Sep 5, 1997 | APPR |
Top Applicants
- Alcon Research, Ltd. — 4 clearances
- Johnson & Johnson Surgical Vision, Inc. — 4 clearances
- Bausch & Lomb, Inc. — 1 clearance
- Lenstec, Inc. — 1 clearance
