510(k) · Cleared
Recalled · Class II · 2022Opaque Herrick Lacrimal Plug, 0.3MM,0.5MM,0.7MM, Models HLP3-Opb,HLP50OPB,HLP7-Opb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lacrimedics, Inc. · LZU Plug, Punctum
Cleared on Jul 1, 2002 after a 27-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Jul 1, 2002
- Review
- 27 days
- Class
- Class U
- Product code
- LZU
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|---|
| Jan 17, 2022 | Class II | Z-0708-2022 | Packaging process control | The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. |
No ancestor or descendant has a Class I recall.
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 | — |
What is it indicated for?
OPAQUE Herrick Lacrimal Plugs may be used in thc heatment of:
*Dry Eye symptoms:dryncss, redness, itching, buniiiig, interrnitrcnt tearing or foreign body sensation.
4 For treatment of ocular dryness secoiidary to contact lens USC.
To enhance tlic e.flicacy of topical ocular rhedications.
-After surgery to prcvent complications due to Dry Eye.
- For the Dry Lye component of: conjunctivitis, keratitis, csriical ulcer, ptmygium blepharitis, red lid margins, recurrent chalazioa, cornea1 erosion, filamentary keratitis ‘nd other eye diseases.
OPAQUE Wcnick Lacrimal Plugs are indicated by the patient’s positive response to The Lacrimal Efficiency T e s P with dissolvable pIugs (Lacrimedics).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021831 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021831: Opaque Herrick Lacrimal Plug, 0.3MM,0.5MM,0.7MM, Models HLP3-Opb,HLP50OPB,HLP7-Opb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021831
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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