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XEN 45 Glaucoma Treatment System (2015-12-14)
- Starting date:
- December 14, 2015
- Posting date:
- January 7, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-56556
Affected Products
A. XEN 45 Glaucoma Treatment System
Reason
Surgeons may encounter a higher than expected force to actuate slider mechanism on some XEN injectors when they are in the process of implanting the XEN 45 gel stent which may lead to ocular trauma especially when surgeon forces slider mechanism forward.
Affected products
A. XEN 45 Glaucoma Treatment System
Lot or serial number
- 60815
- 60869
Model or catalog number
- 5507-001
Companies
- Manufacturer
-
Aquesys Inc.
26970 Aliso Viejo Parkway, Suite 200
Aliso Viejo
92656
California
UNITED STATES