Events

Rappel de Device Recall VisiPlugST or CollaSyn Plugs

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Lacrimedics Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    70036
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1081-2015
  • Date de mise en oeuvre de l'événement
    2014-11-26
  • Date de publication de l'événement
    2015-02-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132171
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Plug, punctum - Product Code LZU
  • Cause
    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
  • Modèle / numéro de série
    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;
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Lacrimedics Inc, 2620 Williamson Place NW, Suite 113, DuPont WA 98327
  • Société-mère du fabricant (2017)
    Lacrimedics Inc
  • Source
    USFDA