Lacrimedics Inc: Medical Device Recall in 2015 - (Recall #: Z-1081-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: November 26, 2014

Date Posted: February 18, 2015

Recall Number: Z-1081-2015

Event ID: 70036

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.

Status: Terminated

Product Quantity: 781 units

Code Information:

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;

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated