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

Catalog Number	5507-001
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Healthcare professional reported a xen®45 gts "implant broken due to defective slider" during implantation in left eye.Device available for return.Surgery was completed with second xen®45 gts device.No eye injury noted.
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.
Additional Manufacturer Narrative
Device analysis: a visual evaluation of the xen injector was performed.No damage was observed.A functionality test was performed.During the functionality test, smooth operation of the slider knob in each bevel position (traveling the entire distance) was observed and the needle moved in tandem with the slider knob which meets the expected result.Slider resistance is not verified since , smooth operation of the slider knob in each bevel position (traveling the entire distance) was observed and the needle moved in tandem with the slider knob during the functionality test.Additional, changed, and/or corrected data: d9, h3, h6.
Event or Problem Description
Healthcare professional reported a xen®45 gts "implant broken due to defective slider" during implantation in left eye.Device available for return.Surgery was completed with second xen®45 gts device.No eye injury noted.

• 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: 24379585
• Report Number: 3011299751-2026-00021
• Device Sequence Number: 16016997
• Product Code: KYF
• UDI-Device Identifier: 10888628032439
• UDI-Public: (01)10888628032439(10)64984(11)231026(17)261031
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K161457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 5507-001
• Device Lot Number: 64984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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