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SuperFlex

KATENA PRODUCTS, INC. · Model 3172J · UDI-DI 00841668115015

LZU Prescription
1
510(k) clearances
163
Adverse events
4
Recalls
37
Facilities

Description

SuperFlex Punctum Plug 1.2mm D x 2.0mm L - Twin Pack

Recalls

DateFirmReason
2022-01-17Lacrimedics IncThe sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
2022-01-17Lacrimedics IncThe sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
2014-11-26Lacrimedics IncMoisture 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.
2006-07-06Oasis Medical IncLabeled with an incorrect diameter

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.