FDANovember 26, 2014device
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 upp...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
lacrimedics
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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