Device Recall VisiPlugST or CollaSyn Plugs

  • Model / Serial
    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;
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    No
  • 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 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Lacrimedics Inc, 2620 Williamson Place NW, Suite 113, DuPont WA 98327
  • Manufacturer Parent Company (2017)
  • Source
    USFDA