VisiPlugST for the Lacrimal Efficiency Test — Class III medical device recall Z-1081-2015
Terminated recall by Lacrimedics Inc, reported 2015-02-18, distributed nationwide. Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon contact. The firm'
| Recall number | Z-1081-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lacrimedics Inc, DuPont, WA, United States |
| Recall initiated | 2014-11-26 |
| Classified | 2015-02-10 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2015-03-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CH, CZ, FR, GB, IE, MX, PE |
| Quantity | 781 units |
| Reason classes | device malfunction |
| Lot numbers | 072314-2328, 072314-2329, 072314-2330, 081314-2365, 081314-2366, 081314-2367, 091814-2345, 091814-2350, 100614-2344 |
| Model numbers | 1813, 1814, 1815, 1903, 1904, 1905 |
Product
VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Plugs are place in the upper and/or lower horizontal canaliculus. Two plugs are placed into a foam carrier and nitrogen sealed inside a foil pouch. The foil pouch is sent to sterilizer for gamma sterilization. Two sterile pouches are packaged in a box with an IFU.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1081-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.