MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT INJECT W TRABECULAR MICRO-BYPASS SYSTEM MODEL IS2; INTRAOCULAR PRESSURE LOWERING IMPLANT

Model Number	IS2-JP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a trabecular microbypass stent system procedure, the surgeon experienced difficulty implanting the stents, and the trocar tip broke off.Per report, both stents were successfully implanted without the trocar tip, and the procedure was completed with no adverse patient impact.The report noted that the trocar fragment was located outside of the patient's eye near the incision site, and was retrieved.The report also noted that surgical technique was a large contributing factor to the trocar fragmentation.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: a6: race noted as japanese.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).
Additional Manufacturer Narrative
Additional information: b5, g2, g3.Mfr# reference: (b)(4).
Event or Problem Description
Through follow-up, the following additional information was received.Per report, the surgeon believes that stress on the trocar during the procedure contributed to the event.Reportedly, there was no adverse patient impact.
Additional Manufacturer Narrative
Additional information: d9, g2, g3, h3.The device was returned nested in the thermoform packaging tray with the trocar tip taped on a surgical gauze, and no stents were returned.The device evaluation was completed, and the trocar was found broken.This finding may have occurred during the surgical procedure, likely during the deployment of the second stent.No other non-conformances related to the reported event were found.Based on these findings, the root cause of the customer¿s reported issue was not conclusively identified; however, the most likely cause is a heavily bias trocar during the deployment of the second stent.Mfr# reference: (b)(4).

• Brand Name: ISTENT INJECT W TRABECULAR MICRO-BYPASS SYSTEM MODEL IS2
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• 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: 23562790
• Report Number: 2032546-2025-00120
• Device Sequence Number: 18556812
• Product Code: OGO
• UDI-Device Identifier: 00853704002487
• UDI-Public: 01008537040024871032807717270630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P170043
• 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: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2026

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: IS2-JP
• Device Lot Number: 3280773
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 11/14/2025; 01/28/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 11/24/2025; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• 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 Sex: Unknown
• Patient Race: Asian