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U.S. Department of Health and Human Services

Class 3 Device Recall VisiPlugST or CollaSyn Plugs

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  Class 3 Device Recall VisiPlugST or CollaSyn Plugs see related information
Date Initiated by Firm November 26, 2014
Date Posted February 10, 2015
Recall Status1 Terminated 3 on March 23, 2015
Recall Number Z-1081-2015
Recall Event ID 70036
510(K)Number K140026  
Product Classification Plug, punctum - Product Code LZU
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.
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;          
Recalling Firm/
Manufacturer		 Lacrimedics Inc
2620 Williamson Place NW
Suite 113
DuPont WA 98327
For Additional Information Contact Brian P. Logan
253-964-0360
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZU and Original Applicant = LACRIMEDICS, INC.
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