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Comfortear™
MICROSPECIALITIES, INC. · Model 24-2007 · UDI-DI 10810003223552
LZU
Prescription
1
510(k) clearances
163
Adverse events
4
Recalls
37
Facilities
Description
Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomically designed Comfortear™ Insertion Tool in an impact-minimizing tray. Packaged two (2) individual sterile trays per box, the Comfortear™ individual sterile trays reduce the potential for unnecessary waste when only a single occulder is required. Medium, 0.8mm.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-17 | Lacrimedics Inc | The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. |
| 2022-01-17 | Lacrimedics Inc | The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. |
| 2014-11-26 | Lacrimedics Inc | 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. |
| 2006-07-06 | Oasis Medical Inc | Labeled with an incorrect diameter |
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Get your free API keyRead the docsData 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.