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

Catalog Number	5507-001
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Healthcare professional reported a xen®45 gts "upon opening the device box, "[hcp]" found the word 'failure' written on the side and the sterilization seal was missing.The device had been tampered with and was not sterile.".
Event or Problem Description
Additionally, healthcare professional reported device did not make patient contact.Surgery was completed with backup device in right eye.
Additional Manufacturer Narrative
Further information regarding event, product, or patient details has been requested.No additional information is available at this time.
Additional Manufacturer Narrative
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.Additional, changed, and/or corrected data: a2, a3a, b5, d4, h4, 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: 50736582
• Report Number: 3011299751-2026-00086
• Device Sequence Number: 10586983
• Product Code: KYF
• UDI-Device Identifier: 10888628032439
• UDI-Public: (01)10888628032439(17)261031(10)64984
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 10/02/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 62 YR
• Patient Sex: Male