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Hello, eyes
Bio Optics Co., Ltd · Model BIO Plug 0.3 · UDI-DI 08800024300672
1
510(k) clearances
163
Adverse events
4
Recalls
37
Facilities
Description
Our BIO Plug is a medical device designed for the treatment of dry eye syndrome. It is inserted into the lacrimal punctum gland to minimize the drainage of tears through the tear duct, thereby alleviating symptoms of dry eye.
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.