# P000046: Staarvisc II

- Pathway: PMA
- Applicant: Anika Therapeutics, Inc.
- Decided: Apr 18, 2001 after 163 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
- Jul 18, 2005 · Not classified · Z-1106-05: Sterility may be compromised.
- Jul 14, 2005 · Not classified · Z-1383-05: Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
- Jul 14, 2005 · Not classified · Z-1382-05: Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
- Oct 8, 2003 · Not classified · Z-0109-04: Stability failure at the 20 month for viscosity specification

Source page: https://510kreport.com/device/P000046
Methodology: https://510kreport.com/methodology