# P810031: Healon, Healon GV, HEALON5 Products Sodium Hyaluronate Ophthalmic Viscoelastic Devices

- Pathway: PMA
- Applicant: Johnson & Johnson Surgical Vision, Inc.
- Decided: Jan 14, 1983 after 556 days
- Product code: LZP (Aid, Surgical, Viscoelastic)
- Device class: 3
- Regulation: 21 CFR 886.4275
- Recalls of this device: 8 (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
- Dec 3, 2019 · Class II · Z-0867-2020: Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Also, reports of clogging of phacoem
- Apr 1, 2017 · Class II · Z-2063-2017: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
- Apr 1, 2017 · Class II · Z-2064-2017: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
- Apr 1, 2017 · Class II · Z-2067-2017: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
- Apr 1, 2017 · Class II · Z-2062-2017: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
- Apr 1, 2017 · Class II · Z-2065-2017: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
- Apr 1, 2017 · Class II · Z-2066-2017: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
- 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/P810031
Methodology: https://510kreport.com/methodology