FDA product code LZP: Aid, Surgical, Viscoelastic
LZP is the FDA product code for aid, surgical, viscoelastic. It is a Class III device, regulated under 21 CFR 886.4275 and reviewed by the Ophthalmic panel. Devices under LZP reach the market by PMA; FDA lists no cleared 510(k)s for it. 14 PMA applications cite this product code. FDA has posted 25 recalls for LZP devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Aid, Surgical, Viscoelastic |
| Device class | Class III |
| Regulation | 21 CFR 886.4275 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | PMA |
Recalls for LZP devices
25 product recalls in 10 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-07-31.
| Year | Recalls |
|---|---|
| 2017 | 6 |
| 2019 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LZP?
LZP is the FDA product code for aid, surgical, viscoelastic. It is a Class III device, regulated under 21 CFR 886.4275 and reviewed by the Ophthalmic panel.
What device class is LZP?
Class III, regulation 21 CFR 886.4275. Typical premarket route: PMA.
Have LZP devices been recalled?
Yes: 25 product recalls across 10 recall events; the most recent began 2026-07-31.
Next steps
- Run an FDA pathway report with predicate devices for product code LZP
- Run a recall and safety report across every LZP manufacturer
- Watch product code LZP 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times