# P960011: Biolon 1% Sodium Hyaluronate Viscoelastic Surgical Aid Fluid

- Pathway: PMA
- Applicant: Altacor, Ltd.
- Decided: Jul 16, 1998 after 806 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 4, 2010 · Not classified · Z-0606-2011: Finger flange on the BD 1% OVD syringe can disengage during cataract surgery and and may lead to injury.

Source page: https://510kreport.com/device/P960011
Methodology: https://510kreport.com/methodology