XEN-45 Glaucoma Treatment System (2019-10-23)
- Starting date:
- October 23, 2019
- Posting date:
- November 8, 2019
- 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-71549
Last updated: 2019-11-08
Affected Products
XEN-45 Glaucoma Treatment System
Reason
During an inspection process, a small number of units in an unreleased XEN 45 lot were observed to have trace amounts of polishing compounds that are used in the needle sleeve manufacturing process.
Affected products
XEN-45 Glaucoma Treatment System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5507-01-01
Companies
- Manufacturer
-
Allergan, Inc.
2525 DUPONT DRIVE
Irvine
92612
California
UNITED STATES