Product code MFK
- Device name
- Lens, Multifocal Intraocular
- Medical specialty
- Ophthalmic
- Device class
- 3
- Regulation number
- 886.3600
- Review panel
- OP
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P240005S008 | enVista Envy™ Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | 2026-09-30 |
| P060011S045 | RayOne Galaxy; Model RAO605G, RayOne Galaxy Toric; Model RAO615X | Rayner Intraocular Lenses , Ltd. | 2026-09-24 |
| P240005S007 | enVista Envy™ hydrophobic acrylic intraocular lens (IOL) | Bausch & Lomb, Inc. | 2026-09-03 |
| P240005S005 | enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) | Bausch & Lomb, Inc. | 2026-08-12 |
| P240005S006 | enVista Envy™ Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | 2026-07-22 |
| P040020S120 | AcrySof ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL | Alcon Research, Ltd. | 2026-07-06 |
| P040020S121 | AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. | 2026-07-02 |
| P040020S119 | AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL | Alcon Research, Ltd. | 2026-07-02 |
| P080010S031 | TECNIS™ 3-Piece Multifocal, Model ZMA00 | Johnson & Johnson Surgical Vision, Inc. | 2026-06-03 |
| P200020S012 | Clearview 3 | Lenstec, Inc. | 2026-04-15 |
| P200020S011 | ClearView 3 IOL | Lenstec, Inc. | 2026-03-25 |
| P040020S118 | AcrySof® IQ ReSTOR Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. | 2026-03-02 |
| P080010S030 | TECNIS Multi-focal 3-pc, ZMA00 | Johnson & Johnson Surgical Vision, Inc. | 2026-01-12 |
| P040020S117 | AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. | 2025-12-12 |
| P200020S010 | ClearView 3 | Lenstec, Inc. | 2025-12-04 |
| P040020S116 | AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. | 2025-09-18 |
| P080010S027 | TECNIS Multifocal 3-Piece IOL | Johnson & Johnson Surgical Vision, Inc. | 2025-09-10 |
| P080010S029 | TECNIS 3-Piece Multifocal, Model ZMA00 | Johnson & Johnson Surgical Vision, Inc. | 2025-09-02 |
| P040020S115 | AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses\s | Alcon Research, Ltd. | 2025-08-25 |
| P200020S009 | ClearView 3 Lens | Lenstec, Inc. | 2025-08-12 |
| P240005S003 | enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) | Bausch & Lomb, Inc. | 2025-07-30 |
| P080010S028 | TECNIS 3-Piece Multifocal, Model ZMA00 | Johnson & Johnson Surgical Vision, Inc. | 2025-07-22 |
| P040020S111 | AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. | 2025-06-18 |
| P240005S004 | enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) | Bausch & Lomb, Inc. | 2025-05-30 |
| P040020S113 | AcrySof ReSTOR Posterior Chamber Intraocular Lens (IOL) | Alcon Research, Ltd. | 2025-02-14 |
| P040020S112 | AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. | 2025-02-04 |
| P240005S001 | enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) | Bausch & Lomb, Inc. | 2025-01-14 |
| P080010S026 | TECNIS 3-Piece Multifocal | Johnson & Johnson Surgical Vision, Inc. | 2024-12-19 |
| P240005S002 | enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) | Bausch & Lomb, Inc. | 2024-12-11 |
| P200020S007 | MFK IOL | Lenstec, Inc. | 2024-10-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05029867007170 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007316 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007309 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007293 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007286 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007279 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007262 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007255 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007248 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007231 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007224 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007217 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007200 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007194 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007187 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007026 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007163 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007156 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007149 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007132 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007125 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007118 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007101 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007095 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007088 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007071 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007064 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007057 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007040 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |
| 05029867007033 | RayOne Galaxy | RAYNER INTRAOCULAR LENSES LIMITED | 2026-09-29 |