MAUDE Adverse Event Report: ALLERGAN (IRVINE) XEN 45 GTS; IMPLANT, EYE VALVE

Catalog Number	5513-001
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The event is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a xen®45 gts "would not advance correctly." device did not make patient contact.Surgery was completed with backup device in the right eye.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: d9, h3, h6.Device analysis: one xen 45 glaucoma treatment system (gts) injector was received with the slider knob of the injector between the start and end positions.A non-abbvie black rubber cover was received attached to the needle end of the injector upon receipt.The covering was removed upon receipt to properly visualize the receipt condition of the injector.Upon removal of the black cover, the bevel selector was observed to be partially torn.Slider resistance is unable to verify since a functionality test could not be performed due to the condition of the bevel selector.The complainant did not report that the bevel selector was damaged.The condition of the bevel selector is likely due to complainant handling.
Event or Problem Description
Healthcare professional reported a xen®45 gts "would not advance correctly." device did not make patient contact.Surgery was completed with backup device in the right eye.

• Brand Name: XEN 45 GTS
• Common Device Name: IMPLANT, EYE VALVE
• Manufacturer (Section D): ALLERGAN (IRVINE); 2525 dupont drive; irvine CA 92612
• Manufacturer (Section G): ALLERGAN (IRVINE); 2525 dupont drive; irvine CA 92612
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 24688571
• Report Number: 3011299751-2026-00048
• Device Sequence Number: 18573509
• Product Code: KYF
• UDI-Device Identifier: 10888628032439
• UDI-Public: (01)10888628032439(10)65381(11)241106(17)271130
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5513-001
• Device Lot Number: 65381
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown