MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT INFINITE TRABECULAR MICRO-BYPASS SYSTEM; AQUEOUS SHUNT

Model Number	IS3-WW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Visual Disturbances (2140); Corneal Endothelial Cell Loss (4806)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: h6 (investigation type 5): b10.The device was returned nested in the thermoform packaging tray, and no stents were returned.The device evaluation was completed, and the injector¿s trocar was found bent.This finding likely occurred during the surgical procedure.No non-conformance's were found.The device history record review of the manufacturing lot was performed and there were no non-conformities found to be related to the reported event.A review of the device labeling and associated risk documents was completed.Corneal edema, corneal endothelial cell loss, and decreased/impaired vision are identified in the labeling as known inherent risks of trabecular micro-bypass stent procedure.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.An adverse event appears to have occurred but does not appear to have been a problem with the device or the way it was used.Corneal edema, corneal endothelial cell loss, and decreased/impaired vision are established risks associated with use of the device, which is clearly specified in the product's labeling.Based on the device evaluation findings and the information received, the root cause of the reported events (corneal edema, corneal endothelial cell loss, and decreased/impaired vision) was not conclusively identified.However, the most likely cause of the bent trocar is a heavily bias trocar during stent deployment.Mfr# reference: (b)(4).
Event or Problem Description
Initially it was reported that during a right eye (od) trabecular microbypass stent system procedure, the surgeon noticed that the trocar was "bent" but was able to successfully implant three (3) stents.Per report approximately five (5) weeks postop, the patient "did not have a good recovery in the cornea" and the surgeon requested a device evaluation.Through follow-up, the following additional information was received.Reportedly during stent implantation, the guide wire became embedded within the corneal stroma and bent at an angle, which required withdrawing the injector and attempting to "straighten it" to allow implantation of the remaining stents.Per report, the event resulted in decreased vision as compared to preoperative state due to epithelial edema and "significant" decrease in endothelial cell count.The report noted that a "narrow corneal incision" contributed to the event.Per report, the patient is currently stable with improvement in the corneal condition, and the event resolved with sequalae.

• Brand Name: ISTENT INFINITE TRABECULAR MICRO-BYPASS SYSTEM
• Common Device Name: AQUEOUS SHUNT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer (Section G): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: brittany massey ; 229 avenida fabricante; san clemente, CA 92672 ; 949367960
• MDR Report Key: 24974330
• Report Number: 2032546-2026-00028
• Device Sequence Number: 14665049
• Product Code: KYF
• UDI-Device Identifier: 00853704002470
• UDI-Public: 01008537040024701032905417270430
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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 Model Number: IS3-WW
• Device Lot Number: 329054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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: 89 YR
• Patient Sex: Unknown
• Patient Race: White