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.
Recall
- Recall Number
- Z-1081-2015
- Event Number
- 70036
- Firm
- Lacrimedics Inc
- FEI Number
- 2024818
- Product Code
- LZU
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 26, 2014
- Posted
- February 10, 2015
- Terminated
- March 23, 2015
- Address
- 2620 Williamson Place NW, Suite 113, DuPont, WA, 98327
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.
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.
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.
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.
781 units