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	02/24/2026
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 "unable to move smoothly and stuck when trying to deploy" in left eye.Surgery was completed with backup device.
Event or Problem Description
Healthcare professional reported a xen®45 gts "unable to move smoothly and stuck when trying to deploy" in left eye.Surgery was completed with backup device.
Additional Manufacturer Narrative
Device analysis: one xen 45 glaucoma treatment system (gts) injector was received.The slider position appears to be between the start and the end position, however, since the slider knob was not properly positioned within the track of the cam, proper determination of slider position cannot be made.A stent was not observed within the returned packaging.It is unknown whether the stent is within the injector.The complainant did not report that the slider knob was mispositioned.The condition of the mispositioned slider knob tab is likely due to complainant handling.No further evaluation of this damage is required.Slider resistance and injector was unable to verify since the injector was received with the slider knob mispositioned.It is unknown if internal components are properly aligned; therefore, functional evaluation cannot be performed.The complainant did not report that the slider knob was mispositioned.The condition of the mispositioned slider knob is likely due to complainant handling.No further evaluation of this damage is required.Additional, changed, and/or corrected data: d9, h3, h6.

• 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 ; +1(847)936-6324
• MDR Report Key: 24592604
• Report Number: 3011299751-2026-00044
• Device Sequence Number: 8933551
• Product Code: KYF
• UDI-Device Identifier: 10888628032439
• UDI-Public: (01)(01)10888628032439
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/18/2026

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
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 09/18/2026
• 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