Home › Allergan, Inc. › XEN Glaucoma Treatment System
XEN Glaucoma Treatment System
Allergan, Inc. · Model 5513-001 · UDI-DI 10888628032439
KYF
Prescription
1
510(k) clearances
4,319
Adverse events
6
Recalls
18
Facilities
Description
XEN Sterile Injector US
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-10-30 | Allergan PLC | Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to th |
| 2016-02-22 | Innovative Ophthalmic Products, Inc | Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package insert/Instructions for Use (IFU) for the device has been updated to add a cau |
| 2006-04-12 | Eagle Vision Inc | Product may have deformed valves which would cause the valve not to operate properly. |
| 2006-04-12 | Eagle Vision Inc | Product may have deformed valves which would cause the valve not to operate properly. |
| 2006-04-12 | Eagle Vision Inc | Product may have deformed valves which would cause the valve not to operate properly. |
| 2006-04-12 | Eagle Vision Inc | Product may have deformed valves which would cause the valve not to operate properly. |
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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.