# P880031: Vitrax   Sodium Hyaluronate

- Pathway: PMA
- Applicant: Abbott Medical Optics, Inc.
- Decided: Aug 10, 1989 after 479 days
- Product code: LZP (Aid, Surgical, Viscoelastic)
- Device class: 3
- Regulation: 21 CFR 886.4275
- Recalls of this device: 1 (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 29, 2008 · Not classified · Z-0343-2009: Endotoxin levels above specifications have been noted in some syringes tested for lot number UD30654 of the AMO Healon D Ophthalmic Viscosurgical Device. Endotoxin levels above the maximum USP level m

Source page: https://510kreport.com/device/P880031
Methodology: https://510kreport.com/methodology