Risk Management
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Xen glaucoma device recall
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Allergan has announced a voluntary recall of its Xen® 45 Glaucoma Treatment System (XEN 45 Gel Stent preloaded into a Xen® Injector).
Allergan announcement sent to the American Glaucoma Society
“As of Friday October 18th, 2019, Allergan reached out to surgeons to inform them that unused XEN 45 devices are on hold in the U.S. and globally. Consequently, the Company recommended surgeons postpone any upcoming surgeries using XEN and not implant any unused XEN devices currently in their practice/office/surgical suite/OR. Since then, Allergan has voluntarily recalled all lots of XEN® Glaucoma Treatment System (XEN® 45 Gel Stent preloaded into a XEN® Injector). Healthcare providers will receive a recall letter by October 31, 2019 to return unused XEN products. Allergan has informed the U.S. Food and Drug Administration of this voluntary recall.
This recall is being conducted down to the Retail (Health Care Provider) Level. It is important to note that explanting implanted devices is not being recommended; this recall is a retrieval of un-implanted inventory.
During in-process inspection, 4 (four) units in an unreleased XEN® 45 lot were observed to have trace amounts of residual polishing compounds that are used in the needle sleeve manufacturing process. A review of the field safety reports has not detected any safety signals or adverse trends associated with the residual polishing compounds.
For any question regarding XEN or to report any adverse events, please contact Product Surveillance at 1-800-624-4261. Allergan anticipates resupply of XEN45® to U.S. market in mid-December.”
Patient care advice from Allergan
On October 31, 2019, Allergan sent letters to physicians who had received the affected lots. Recalled devices were distributed from 2017 to 2019. The letter contained this advice about patient care:
- Continue your normal postoperative care.
- Explanting implanted devices is not recommended.
- Report any serious adverse events to Allergan Product Surveillance.
Notifying patients
- Send a Letter about the Xen recall to patients who have devices from recalled lots.
- Our sample letter explains that there are no known adverse patient outcomes, and that the device does not need to be removed.
- Send the letter via regular mail, and place a copy in the patient’s medical record.
