510(k) · Cleared
ClearedTemporary Intracanalicular Collagen Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eagle Vision, Inc. · LZU Plug, Punctum
Cleared on May 16, 1989 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- May 16, 1989
- Review
- 82 days
- Class
- Class U
- Product code
- LZU
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK890919 Temporary Intracanalicular Collagen ImplantEagle Vision, Inc. · 1989
- Descendant · cites it directly · 4 of its ownK140711 Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable…Paragon Bioteck, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK150288 PDO Absorbable Punctum PlugRiverpoint Medical · 2015
- Descendant · 3 generations on · 2 of its ownK162361 Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK013613 Soft Plug Absorbable Plug-SAOasis Medical, Inc. · 2002 · Recalled
- Descendant · 4 generations on · 0 of its ownK241229 Hello,eyes® BIO PlugBio Optics Co., Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K140711Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum Plug…Paragon Bioteck, Inc. · 2014 · cites it directly4descendants
- K150288PDO Absorbable Punctum PlugRiverpoint Medical · 2015 · 2 generations on3descendants
- K162361Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. · 2017 · 3 generations on2descendants
- K013613Soft Plug Absorbable Plug-SAOasis Medical, Inc. · 2002 · cites it directly1descendant
- K241229Hello,eyes® BIO PlugBio Optics Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890919 | Temporary Intracanalicular Collagen Implant | Eagle Vision, Inc. | 1989 | — |
| +1 | K140711 | Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum… | Paragon Bioteck, Inc. | 2014 | — |
| +2 | K150288 | PDO Absorbable Punctum Plug | Riverpoint Medical | 2015 | — |
| +3 | K162361 | Soft Plug Extended Duration 180 Canalicular Plug | Oasis Medical, Inc. | 2017 | — |
| +1 | K013613 | Soft Plug Absorbable Plug-SA | Oasis Medical, Inc. | 2002 | 1 |
| +4 | K241229 | Hello,eyes® BIO Plug | Bio Optics Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZU device
- #1 K241229 Hello,eyes® BIO Plugscore 8.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K140711 (Paragon Bioteck, Inc., 2014) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LZU devicesLZU Plug, Punctum: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZU
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LZU
148in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZU
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZU
3in 2025
MAUDE reports naming product code LZU, 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 | 10 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 1 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 17 |
| 2014 | 3 | 148 | 0 | 10 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 2 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K890919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K890919: Temporary Intracanalicular Collagen Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K890919
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026