# P810025: Amvisc (R)

- Pathway: PMA
- Applicant: Bausch & Lomb, Inc.
- Decided: Oct 18, 1983 after 873 days
- Product code: LZP (Aid, Surgical, Viscoelastic)
- Device class: 3
- Regulation: 21 CFR 886.4275
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 8, 2003 · Not classified · Z-0112-04: Stability failure at the 20 month for viscosity specification
- Oct 8, 2003 · Not classified · Z-0113-04: Stability failure at the 20 month for viscosity specification
- Oct 8, 2003 · Not classified · Z-0110-04: Stability failure at the 20 month for viscosity specification
- Oct 8, 2003 · Not classified · Z-0111-04: Stability failure at the 20 month for viscosity specification

Source page: https://510kreport.com/device/P810025
Methodology: https://510kreport.com/methodology