PMA · Approved
Recalled · Class II · 2019Healon, Healon GV, HEALON5 Products Sodium Hyaluronate Ophthalmic Viscoelastic Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Surgical Vision, Inc. · LZP Aid, Surgical, Viscoelastic
Approved on Jan 14, 1983 through premarket approval, which rests on the device’s own clinical evidence after a 556-day review. It has been recalled 8 times.
- Decided
- Jan 14, 1983
- Review
- 556 days
- Class
- Class III
- Product code
- LZP
- Recalls
- 8
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P810031 has 75 supplements since 1983: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1983 | 1 |
| 1984 | 4 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| 1999 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| 2006 | 5 |
| 2007 | 3 |
| 2008 | 2 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 4 |
| 2013 | 5 |
| 2014 | 1 |
| 2015 | 4 |
| 2016 | 4 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 4 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 5 |
| 2026 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2019 | Class II | Z-0867-2020 | Labeling False and Misleading | 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 phacoemulsion equipment tubing, which may… |
| Apr 1, 2017 | Class II | Z-2063-2017 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Unknown/Undetermined by firm | 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 further than intended, resulting in… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LZP devicesLZP Aid, Surgical, Viscoelastic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZP
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZP
Too few LZP 510(k)s in any year since 2007 to give a median.
Recalls per year · LZP
1in 2019
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LZP
64in 2025
MAUDE reports naming product code LZP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | — | 0 | 58 |
| 2008 | 21 | — | 1 | 203 |
| 2009 | 11 | — | 0 | 34 |
| 2010 | 16 | — | 1 | 157 |
| 2011 | 13 | — | 0 | 106 |
| 2012 | 29 | — | 0 | 140 |
| 2013 | 21 | — | 1 (1) | 83 |
| 2014 | 17 | — | 1 | 119 |
| 2015 | 11 | — | 0 | 68 |
| 2016 | 12 | — | 0 | 136 |
| 2017 | 18 | — | 0 | 162 |
| 2018 | 8 | — | 0 | 113 |
| 2019 | 5 | — | 1 | 156 |
| 2020 | 13 | — | 0 | 132 |
| 2021 | 15 | — | 0 | 157 |
| 2022 | 8 | — | 0 | 184 |
| 2023 | 13 | — | 0 | 107 |
| 2024 | 10 | — | 0 | 76 |
| 2025 | 13 | — | 0 | 64 |
| 2026 | 7 | — | 1 | — |
https://510kreport.com/device/P810031 · printed Nov 6, 2026
Cite this page
510(k) Report. “P810031: Healon, Healon GV, HEALON5 Products Sodium Hyaluronate Ophthalmic Viscoelastic Devices.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P810031
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026