VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model...
FDA Recall #Z-1081-2015 — Class III — November 26, 2014
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.
Recalling Firm
Lacrimedics Inc — DuPont, WA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
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.
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;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated