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

Catalog Number	5513-001
Medical Device Problem Codes	Fracture (1260); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Erosion (1750); Endophthalmitis (1835); Loss of Vision (2139)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) reported they underwent xen®45 gts implantation via ab-externo in left eye.Pod1, hcp reported shallow bleb; which resolved on pod6.Post-operative month eight, patient reported eye became red and itchy, moderate painful eye, blurred vision, headache, photophobia, red eye, swelling in eyelid, tearing, and jaw pain.On pod239, hcp diagnosed endophthalmitis and slit lamp examination showed broken xen and xen eroded through conjunctiva; provided treatment of moxi.Q1, pred.Qid, diamox 250 bid, and levaquin 750 qd.On pod240, endophthalmitis is worse, loss of peripheral vision, blurred vision, pain, eye redness, nausea, and vomiting; slit lamp showed cornea edema.Later on pod240, treating hcp noted they could not see the stent and provided intravitreal vancomycin, ceftazidime, and zofran.On pod315, iop was 1 mmhg, proximal segment of stent remains in anterior chamber.Event not resolved.
Additional Manufacturer Narrative
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 events are a known potential adverse event addressed in the product labeling.
Event or Problem Description
Additional information reported via regulatory agency reporting that the broken part of the stent that eroded was removed.The nausea and vomiting patient ultimately experienced led them to go to the emergency room that day where they were given a pain medication and liquid iv fluid.Patient reports the implanting hcp informed them on pod 240 that vision had been lost in the left eye.Antibiotic injections provided on this date by retina specialists and also the next day.The retina specialist reportedly told patient they did not believe there was any possibility of recovering their sight.Patient was informed by their implanting surgeon that scar tissue has formed around the stent and it should cause no further issues.
Additional Manufacturer Narrative
This is in response to mw5184999.

• 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: 24328721
• Report Number: 3011299751-2026-00017
• Device Sequence Number: 13269501
• Product Code: KYF
• UDI-Device Identifier: 10888628032439
• UDI-Public: (01)10888628032439(10)65142(11)240301(17)270331
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: 5513-001
• Device Lot Number: 65142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACETAZOLAMIDE.; AMLODIPINE.; CELECOXIB.; OMEPRAZOLE.
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 68 KG