FDA product code POE: Extended Depth Of Focus Intraocular Lens
POE is the FDA product code for extended depth of focus intraocular lens. It is a Class III device, regulated under 21 CFR 886.3600 and reviewed by the Ophthalmic panel. Devices under POE reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 1 recall for POE devices, 1 initiated in the last five years.
Definition
Intended to be implanted to replace the natural lens of an eye.
Classification
| Field | Value |
|---|---|
| Device name | Extended Depth Of Focus Intraocular Lens |
| Device class | Class III |
| Regulation | 21 CFR 886.3600 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for POE devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-07-06.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code POE?
POE is the FDA product code for extended depth of focus intraocular lens. It is a Class III device, regulated under 21 CFR 886.3600 and reviewed by the Ophthalmic panel.
What device class is POE?
Class III, regulation 21 CFR 886.3600. Typical premarket route: PMA.
Have POE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-07-06.
Next steps
- Run an FDA pathway report with predicate devices for product code POE
- Run a recall and safety report across every POE manufacturer
- Watch product code POE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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