Recall Z-1081-2015— Lacrimedics Inc

Name: FDA recall Z-1081-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-26

Class III · Terminated

Class III FDA medical device recall by Lacrimedics Inc, initiated 2014-11-26, terminated 2015-03-23. It names one FDA 510(k) clearance: K140026. 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: 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..

Recalling firm: Lacrimedics Inc
Classification: Class III
Status: Terminated
Initiated: 2014-11-26
Terminated: 2015-03-23
Firm location: DuPont, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K140026 — COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TESTLacrimedics, Inc.·cleared 2014-06-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.