FDAJanuary 17, 2022device
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
What to do
FDA enforcement status: Ongoing
Brands named
lacrimedics
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACollagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment2022-01-17
- FDAVisiPlugST 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...2014-11-26
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