Z-1081-2015Class III

VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813...

Name: Z-1081-2015 VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813...
Creator: Lacrimedics Inc
Published: 2014-11-26
License: https://open.fda.gov/license/

Lacrimedics, Inc. / initiated 2014-11-26 / Terminated / root cause: manufacturing process

FDA source

Lacrimedics Inc began a recall of 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... on 2014-11-26. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1081-2015
Classification: Class III
Status: Terminated
Initiated: 2014-11-26
Posted: 2015-02-10
Terminated: 2015-03-23
Recalling firm: Lacrimedics, Inc.
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.
Product code: LZU Plug, Punctum
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm notified their foreign consignees on 11/26/14. The firm made a decision to conduct a domestic recall on 12/4/14 and will notify US consignees Consignees will be provided with a return label and request any devices that they still have be returned to the firm. Any consignees that have gone out of business will be sent a certified letter to their last known address. CORRECTIVE ACTIONS: The firm has halted sales of the device until the drying method can be improved. Any remaining stock has been placed in quarantine and will be scrapped.
Quantity in commerce: 781 units
Distribution: Worldwide Distribution-US (nationwide) including the states of AR, CA, FL, ID, IL, KS, MA, MI, NC, NJ, NY, OR, PA, and TX and to the countries of Australia, Brazil, Czech Republic, France, Ireland, Mexico, Peru, Switzerland, and United Kingdom.
Product codes and lots: LOT numbers: 072314-2328; 072314-2329; 072314-2330; 081314-2365; 081314-2366; 081314-2367; 091814-2345; 091814-2350; 100614-2344; EXPIRATION DATES: 2018-05-15; 2018-07-23; 2018-08-13; 2018-08-14; 2018-09-14; 2018-09-14; 2018-09-25; 2018-10-06;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1081-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1081-2015	Class III	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-10

Product code LZU

K140026UnclassifiedCollasyn Plug for the Lacrimal Efficiency TestLacrimedics, Inc. / cleared 2014-06-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)