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	Hyphema (1911); Intraocular Pressure Increased (1937); Fibrosis (3167); Intraocular Pressure Decreased (4468)
Date of Event	07/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Article citation: giansanti f, quaranta g, serino f, vicini g, franco f (2023) comparison of clinical outcomes between xen gel stent and preserflo microshunt: a monocentric experience.J clin exp ophthalmol.14:953 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.The event is a known potential adverse event addressed in the product labeling.
Event or Problem Description
The article "comparison of clinical outcomes between xen gel stent and preserflo microshunt: a monocentric experience" noted 31 eyes were implanted with a xen 45 gel stent and experienced adverse events including 2 eyes experienced early hypotony that was self resolving; 1 eye experienced hyphemia that was self resolving; and 12 eyes experienced filtering bleb fibrosis.Of these 12, 11 eyes required needling with 5-fluorouracil, 3 eyes required bleb revision surgery with mmc 0.02%, and 4 eyes required a further glaucoma surgery consisting of either a trabeculectomy or implantation of another glaucoma valve.

• 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: 24971984
• Report Number: 3011299751-2026-00054
• Device Sequence Number: 17388121
• Product Code: KYF
• UDI-Device Identifier: 10888628032439
• UDI-Public: (01)10888628032439
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K161457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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 Catalogue Number: 5507-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male