Product code POE
- Device name
- Extended Depth Of Focus Intraocular Lens
- 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
- Definition
- Intended to be implanted to replace the natural lens of an eye.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P210005S011 | IC-8 Apthera Intraocular Lens (IOL) | Acu Focus, Inc. | 2025-08-04 |
| P210005S007 | IC-8 Apthera Intraocular Lens (IOL) | Acu Focus, Inc. | 2025-04-25 |
| P210005S009 | IC-8 Apthera IOL Aperture Mask | Acu Focus, Inc. | 2025-03-07 |
| P980040S161 | TECNIS Symfony™ Extended Range Of Vision Intraocular Lens | Johnson & Johnson Surgical Vision, Inc. | 2023-12-22 |
| P210005S006 | IC-8 Apthera intraocular lens (IOL) | Acu Focus, Inc. | 2023-10-30 |
| P210005S005 | IC-8 Apthera Intraocular Lens | Acu Focus, Inc. | 2023-07-31 |
| P210005S003 | IC-8® Apthera™ Intraocular Lens (IOL) | Acu Focus, Inc. | 2022-12-23 |
| P210005S004 | IC-8 Apthera Intraocular Lens (IOL) | Acu Focus, Inc. | 2022-12-02 |
| P210005S002 | IC-8 Apthera Intraocular Lens (IOL) | Acu Focus, Inc. | 2022-09-20 |
| P210005S001 | IC-8 Apthera Intraocular Lens (IOL) | Acu Focus, Inc. | 2022-09-20 |
| P210005 | IC-8 Apthera Intraocular Lens (IOL) | Acu Focus, Inc. | 2022-07-22 |
| P190018S013 | Clareon Vivity™ Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity™ Toric Extended Vision Hydrophobic IO | Alcon Laboratories, LLC | 2022-01-26 |
| P930014S136 | AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL) | Alcon Laboratories, Inc. | 2021-06-22 |
| P980040S112 | TECNIS Symfony OptiBlue IOL, TECNIS Symfomy Toric II OptiBlue IOLs | Johnson & Johnson Surgical Vision, Inc. | 2020-05-28 |
| P980040S109 | TECNIS Symfony PLUS Extended Range of Vision Intraocular Lens (IOL), Model ZHR00, TECNIS Symfony PLUS Extended Range of | Johnson & Johnson Surgical Vision, Inc. | 2020-05-01 |
| P930014S126 | AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A | Alcon Laboratories, Inc. | 2020-02-26 |
| P980040S065 | TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS | Johnson & Johnson Surgical Vision, Inc. | 2016-07-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05050474732407 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732612 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732605 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732599 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732582 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732568 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732551 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732544 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732537 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732520 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732483 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732476 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732469 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732445 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732421 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732148 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732384 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732377 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732353 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732315 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732254 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732247 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732230 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732223 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732216 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732209 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732193 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732186 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732179 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |
| 05050474732162 | TECNIS IOL | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2020-11-09 |