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

Catalog Number	5507-001
Medical Device Problem Codes	Complete Blockage (1094); Material Twisted/Bent (2981); Migration (4003)
Health Effect - Clinical Codes	Corneal Decompensation (1790); Eye Injury (1845); Glaucoma (1875); Intraocular Pressure Increased (1937); Keratitis (1944)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The article "outcomes of the 63-m gelatin microstent versus 45-m gelatin microstent: an international multi-center study" noted patients implanted with the xen 45 gel stent experienced adverse events including 45 eyes were not considered a qualified success at the end of the 12 month follow up (iop greater than 21mmhg); 2 eyes experienced a positive seidel; 5 eyes experienced an encapsulated bleb; 11 eyes experienced a shallow ac; 1 eye experienced iridocorneal touch; 6 eyes experienced choroidals; 6 eyes experienced hyphema; 4 eyes experienced iritis; 2 eyes experienced dellen; 2 eyes experienced vitreous hemorrhage; 2 eyes experienced macular edema; 15 eyes experienced a blocked xen device; 2 eyes experienced a xen-cornea touch; 7 eyes experienced a xen-iris touch; 1 eye experienced a migrated xen; 3 eyes experienced a bent xen; 1 eye experienced corneal decompensation with underlying endothelial dysfunction.Patient underwent descemet's stripping endothelial keratoplasty; 1 eye experienced malignant glaucoma.Patient underwent an iridozonulovitrectomy; and 18 eyes total required needling, 13 with antimetabolite, 5 without.Additional interventions were also carried out including 3 eyes required mmc injection, 15 eyes required 5-fu injection, 3 eyes required an ac tap, 11 eyes required laser to ostomy, 4 eyes required laser to tube, 2 eyes required a laser trabeculoplasty, 2 eyes required xen repositioning, 4 eyes required a xen revision,1 eye required a laser peripheral iridotomy, and 3 eyes required trabeculectomy.In addition, multiple eyes required an additional glaucoma device: 1 received a preserflo, 3 received a baerveldt tube shunt, and 2 received an ahmed valve.
Additional Manufacturer Narrative
Article citation: ghanbarnia, mohammad javad, et al.¿outcomes of the 63-m gelatin microstent versus 45-m gelatin microstent: an international multi-center study.¿ ophthalmology glaucoma, feb.2026, https://doi.Org/10.1016/j.Ogla.2026.01.016.Accessed 13 feb.2026.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 events are a known potential adverse event addressed in the product labeling.

• 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: 24347882
• Report Number: 3011299751-2026-00019
• Device Sequence Number: 9887801
• Product Code: KYF
• UDI-Device Identifier: 10888628032439
• UDI-Public: (01)10888628032439
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/16/2026

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: 02/09/2026
• Initial Report FDA Received Date: 02/16/2026
• 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: 72 YR
• Patient Sex: Male
• Patient Race: White