510(k) · Cleared
Recalled · Class II · 2024Ivalon Pva Surgical Spear, Ivalon Eye Drain, 80CC, Ivalon Eye Drain, 400CC, Ivalon Eye Wick
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M-Pact Worldwide Management Corp. · HOZ Sponge, Ophthalmic
Cleared on Jul 31, 1997 after a 73-day review. The FDA summary names its predicate without a number. It has been recalled 2 times.
- Decided
- Jul 31, 1997
- Review
- 73 days
- Class
- Class II
- Product code
- HOZ
- Recalls
- 2
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HOZ? 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
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Merocel Eye Drain 80cc Named without a submission number | |
| * | — | Merocel Eye Drain 400cc Named without a submission number | |
| * | — | Merocel Eye Wick 8-inch Named without a submission number | |
| * | — | Merocel Surgical Spears Named without a submission number |
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 |
|---|---|---|---|---|
| Oct 22, 2024 | Class II | Z-0798-2025 | Equipment maintenance | Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. |
| Oct 22, 2024 | Class II | Z-0799-2025 | Equipment maintenance | Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All HOZ devicesHOZ Sponge, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HOZ
2in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · HOZ
Too few HOZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HOZ
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HOZ
3in 2025
MAUDE reports naming product code HOZ, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 1 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 3 | 3 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ivalon® Eye Drain 80cc, Eye Drain 400cc, Surgical Spears, and Eye Wick 8-inch are used to absorb fluids from the operative field in ophthalmic surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971832 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971832: Ivalon Pva Surgical Spear, Ivalon Eye Drain, 80CC, Ivalon Eye Drain, 400CC, Ivalon Eye Wick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971832
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026