FDA product code NAA: Lens, Intraocular, Accommodative
NAA is the FDA product code for lens, intraocular, accommodative. It is a Class III device, regulated under 21 CFR 886.3600 and reviewed by the Ophthalmic panel. Devices under NAA reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for NAA devices.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Intraocular, Accommodative |
| Device class | Class III |
| Regulation | 21 CFR 886.3600 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for NAA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-11-14.
Frequently asked questions
What is FDA product code NAA?
NAA is the FDA product code for lens, intraocular, accommodative. It is a Class III device, regulated under 21 CFR 886.3600 and reviewed by the Ophthalmic panel.
What device class is NAA?
Class III, regulation 21 CFR 886.3600. Typical premarket route: PMA.
Have NAA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-11-14.
Next steps
- Run an FDA pathway report with predicate devices for product code NAA
- Run a recall and safety report across every NAA manufacturer
- Watch product code NAA 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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