# P110007: Healon Endocoat Opviscosurgical Ophthalmic Device (Ovd) (3% Sodium Hyaluronate)

- Pathway: PMA
- Applicant: Johnson & Johnson Surgical Vision, Inc.
- Decided: Jul 2, 2012 after 496 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
- Nov 6, 2014 · Class II · Z-0530-2015: AMO has received complaints where the finger grip dislodged while depressing the syringe plunger. The finger grip dislodgement could result in the surgeon's hand unintentionally moving the cannula fur

Source page: https://510kreport.com/device/P110007
Methodology: https://510kreport.com/methodology