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 Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following a right eye (od) trabecular microbypass stent system procedure in conjunction with an intracameral implant procedure, the patient experienced persistent postoperative inflammation, and a possible metal allergy.Per report, the devices were explanted approximately two and a half (2.5) months postoperatively with no complications.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: the device is expected to be returned for evaluation but has not been received at glaukos evaluation center.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.Inflammation and allergic reaction 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.Inflammation and allergic reaction are established risks 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# reference: (b)(4).

• 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 ; +1(949)367-9600
• MDR Report Key: 50508306
• Report Number: 2032546-2026-00076
• Device Sequence Number: 13124171
• Product Code: KYF
• UDI-Device Identifier: 00853704002449
• UDI-Public: 0100853704002449103333391729022821333339US0163
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: 333339
• 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: 08/14/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2026
• 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 Age: 73 YR
• Patient Sex: Female