MAUDE Adverse Event Report: Allergan (Irvine) XEN 45 GTS; implant, eye valve

Catalog Number	5507-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Glaucoma (1875)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is in response to ansm report (b)(4) reference (b)(4).Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.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 reporting a xen®45 gts was implanted in the left eye.Postoperatively, patient experienced "pain, tearing, and a foreign body sensation; which have worsened since implantation." on pod992, patient underwent trabeculectomy.On pod1196, hcp noted "fairly extensive hypertrophic filtration bleb located nasally in the interpalpebral area" is probable cause for discomfort and explanted the device.
Additional Manufacturer Narrative
Device analysis: while preparing to visualize the gel stent, the analyst inadvertently broke the stent into two fragments.It was determined the analyst handling would not impact results of sample testing.The visual inspection was performed on the two fragments.The probable cause for the damage to the gel stent prior to receipt is unknown; however, the gel stent was deployed from the xen injector prior to sample receipt; therefore, handling cannot be ruled out.No further evaluation is required.The events are a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for these events.Additional, changed, and/or corrected data: d9, h3, h6.
Event or Problem Description
Healthcare professional reporting a xen®45 gts was implanted in the left eye.Postoperatively, patient experienced "pain, tearing, and a foreign body sensation; which have worsened since implantation." on pod992, patient underwent trabeculectomy.On pod1196, hcp noted "fairly extensive hypertrophic filtration bleb located nasally in the interpalpebral area" is probable cause for discomfort and explanted the device.

• 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: 50085944
• Report Number: 3011299751-2026-00074
• Device Sequence Number: 18710077
• Product Code: KYF
• UDI-Device Identifier: 10888628032439
• UDI-Public: (01)10888628032439(17)250630(10)64428
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: 5507-001
• Device Lot Number: 64428
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female