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

Model Number	IS3-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: the device was not available; therefore, product testing on the actual device could not be performed.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.Iris damage is identified in the labeling as a known inherent risk 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.Iris damage is an established risk associated with use of the device, which is clearly specified in the product's labeling.Based on the information received, the root cause of the reported event could not be conclusively identified.Mfr# (b)(4).Please reference report 2032546-2026-00037 for the report of iris damage associated with device two (2) of two (2).
Event or Problem Description
It was reported that following the successful implantation of an intracameral implant in the patient's left eye (os) without issue, during a subsequent attempt to implant the first stent from a trabecular microbypass stent system, the stent was "free floating" in the eye.Per report, the surgeon removed the stent using forceps and used a back-up device to complete the procedure with "difficulty" implanting two (2) stents due to "poor" visualization.Additionally, per report, during irrigation and aspiration (i/a), a small quadrant of the iris detached which the surgeon had to "close up".The report noted that the surgeon is unsure if the iris detached during the removal of the free-floating stent or during the subsequent implantation of the stents from the back-up device.The report also noted that intraoperative visibility was compromised due to blood in the operative eye.This report references the report of iris damage associated with device one (1) of two (2).

• 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: 25096453
• Report Number: 2032546-2026-00036
• Device Sequence Number: 5005258
• Product Code: KYF
• UDI-Device Identifier: 00853704002449
• UDI-Public: 01008537040024491033332217290131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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-US
• Device Lot Number: 333322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2026
• 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 Sex: Unknown