FDA product code MXY: Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
MXY is the FDA product code for cannula, ophthalmic, posterior capsular polishing, polyvinyl acetal. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. Devices under MXY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for MXY devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for MXY devices
3 product recalls in 1 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-12-16.
| Year | Recalls |
|---|---|
| 2025 | 3 |
Frequently asked questions
What is FDA product code MXY?
MXY is the FDA product code for cannula, ophthalmic, posterior capsular polishing, polyvinyl acetal. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is MXY?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
Have MXY devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2025-12-16.
Next steps
- Run an FDA pathway report with predicate devices for product code MXY
- Run a recall and safety report across every MXY manufacturer
- Watch product code MXY 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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