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

Model Number	IS3-WW
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
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 complaint history review was completed.The electronic complaint system was searched for the specified lot#.There were no similar issues reported for this lot #.A review of the device labeling including the risk analysis was completed.The reported issue (trocar fragmentation) is identified to be an anticipated hazard.The residual risk for each potential harm was found to be within the insignificant risk region.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that during the implantation of the stents from a trabecular microbypass stent system, the trocar tip broke due to patient movement.There was no report of patient injury.Additional information has been requested.
Additional Manufacturer Narrative
A6: race noted as chinese.Mfr# reference: (b)(4).
Event or Problem Description
Through follow-up, the surgeon reported the following additional information.Per report, the device tip broke during the implantation of the stents in the patient's right eye (od), and the stent was not able to be reloaded.The trocar fragment was retrieved intraoperatively from the patient's eye with no intervention required or postoperative complications.The patient's current status was described as "discharged and recovered" with the event resolved.The report noted that the patient's sudden head movement during implantation contributed to the event.
Additional Manufacturer Narrative
The device was returned nested in the unsealed thermoform packaging tray, and no stents were returned.The device evaluation was completed, and the injector¿s trocar was found bent, not broken as reported.This finding likely occurred during the surgical procedure due to a heavily bias trocar during the deployment of the second stent.No non-conformances related to the reported event were found.Based on these findings, the customer¿s reported issue of a broken trocar was not confirmed; however, the most likely cause of the bent trocar is a heavily bias trocar during the deployment of the second stent.The additional information received through device evaluation was reassessed for reportability criteria; and concluded that the reported event no longer meets the statutory definition of a medical device reportable event.Based on the clarification received, glaukos no longer considers this report as a reportable event.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 ; 949367960
• MDR Report Key: 24298843
• Report Number: 2032546-2026-00012
• Device Sequence Number: 10213301
• Product Code: KYF
• UDI-Device Identifier: 00853704002470
• UDI-Public: 01008537040024701033025317270930
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IS3-WW
• Device Lot Number: 330253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 02/24/2026; 04/21/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/04/2026; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2025
• 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: 68 YR
• Patient Sex: Female
• Patient Race: Asian