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 |
|---|---|---|---|
| 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 |
|---|---|---|---|
| 00380658454562 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454708 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454692 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454685 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454678 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454661 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454654 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454647 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454630 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454623 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454616 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454609 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454593 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454586 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454579 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454418 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454555 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454548 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454531 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454524 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454517 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454500 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454494 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454487 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454470 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454463 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454456 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454449 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454432 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |
| 00380658454425 | Clareon Vivity | Alcon Laboratories, Inc. | 2026-09-04 |