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 |
|---|---|---|---|
| P190018S050 | Clareon Vivity Pro Extended Vision IOLs | Alcon Laboratories, LLC | 2026-10-30 |
| P210005S010 | IC-8 Apthera Intraocular Lens (IOL) | Acu Focus, Inc. | 2026-07-14 |
| 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 |
|---|---|---|---|
| 00380658560423 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560560 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560553 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560546 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560539 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560522 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560515 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560508 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560492 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560485 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560478 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560461 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560454 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560447 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560430 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560270 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560416 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560409 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560393 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560386 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560379 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560362 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560355 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560348 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560331 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560324 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560317 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560300 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560294 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |
| 00380658560287 | CLAREON VIVITY PRO | Alcon Laboratories, Inc. | 2026-11-02 |