FDA product code MTA: Lens, Intraocular, Phakic
MTA is the FDA product code for lens, intraocular, phakic. It is a Class III device, reviewed by the Ophthalmic panel. Devices under MTA reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 8 recalls for MTA devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Intraocular, Phakic |
| Device class | Class III |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MTA devices
8 product recalls in 2 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2026-04-20.
| Year | Recalls |
|---|---|
| 2023 | 7 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code MTA?
MTA is the FDA product code for lens, intraocular, phakic. It is a Class III device, reviewed by the Ophthalmic panel.
What device class is MTA?
Class III. Typical premarket route: PMA.
Have MTA devices been recalled?
Yes: 8 product recalls across 2 recall events; the most recent began 2026-04-20.
Next steps
- Run an FDA pathway report with predicate devices for product code MTA
- Run a recall and safety report across every MTA manufacturer
- Watch product code MTA 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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