Events

Recall of Device Recall VisiPlugST or CollaSyn Plugs

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lacrimedics Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70036
  • Event Risk Class
    Class 3
  • Event Number
    Z-1081-2015
  • Event Initiated Date
    2014-11-26
  • Event Date Posted
    2015-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132171
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Plug, punctum - Product Code LZU
  • 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.
  • 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.

Device

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
    Ophthalmic Devices
  • 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
    Lacrimedics Inc

Manufacturer

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