510(k) · Cleared
Recalled · Class III · 2014Collasyn Plug for the Lacrimal Efficiency Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lacrimedics, Inc. · LZU Plug, Punctum
Cleared on Jun 3, 2014 as substantially equivalent to K895342 (Lacrimedics, Inc., 1989) after a 148-day review. Its family tree reaches back 1 generation to 1989. It has been recalled once.
- Decided
- Jun 3, 2014
- Review
- 148 days
- Class
- Class U
- Product code
- LZU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895342 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK895342 Collagen Implants for the Lacrimal Efficiency TestLacrimedics, Inc. · 1989 · Recalled
- This deviceK140026 Collasyn Plug for the Lacrimal Efficiency TestLacrimedics, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895342 | Collagen Implants for the Lacrimal Efficiency Test | Lacrimedics, Inc. | 1989 | 1 |
| 0 (this device) | K140026 | Collasyn Plug for the Lacrimal Efficiency Test | Lacrimedics, Inc. | 2014 | — |
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 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? (1)
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 |
|---|---|---|---|
| * | K895342 | Collagen Implants for the Lacrimal Efficiency TestSummary page 1…Punctum Plug Product Code: LZU Primary Predicate Devices: Collagen Plugs for the Lacrimal Efficiency Test 510(k): K895342 Device Description: The proposed device is an ophthalmic device commonly referred to as… | 1989 |
| † | K990951 | Maxon** Sterile, Synthetic, Absorbable Suture | 1999 |
| † | K032586 | Caprosyn Absorbable Suture | 2003 |
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 |
|---|---|---|---|---|
| Nov 26, 2014 | Class III | Z-1081-2015 | Nonconforming Material/Component | Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon contact. The firm's data also suggests that a 4 year shelf life may not be sustained. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K895342.
How does its category compare?
All LZU devicesLZU Plug, Punctum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 | — |
What is it indicated for?
VisiPlugs provide temporary occlusion of the tear drainage system. VisiPlugs may be used as:
a diagnostic aid to determine the potential effectiveness of long-term occlusion,
to temporarily enhance the efficacy of topical medications or ocular lubricants,
after surgery to prevent complications due to dry eyes,
to evaluate treatment of ocular dryness secondary to contact lens use,
and to evaluate the dry eye component of ocular surface diseases (OSD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140026: Collasyn Plug for the Lacrimal Efficiency Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140026
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026