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	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following the successful implantation of the first stent and subsequent deployment of the second stent from a trabecular microbypass stent system, "a stent and a metal fragment" were observed inside the patient's right eye (od).Per report, the second stent and the fragment were removed intraoperatively with no report of injury, and a back-up device was used to complete the procedure.The report noted that after the first stent was implanted, a stent was placed at the tip of the "fractured trocar" which became lodged between the tube and the trocar, and the surgeon believes the trocar broke due to pressure applied during deployment.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: the device has been returned to glaukos for evaluation, and the investigation is underway.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
Mfr# reference: (b)(4).
Event or Problem Description
Through follow-up, the following additional information was received.Per report, the patient¿s condition is stable with no postoperative bleeding, no issues with visual acuity, and intraocular pressure (iop) in the low teens.

• 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: 24973584
• Report Number: 2032546-2026-00029
• Device Sequence Number: 16066197
• Product Code: OGO
• UDI-Device Identifier: 00853704002487
• UDI-Public: 01008537040024871033023117270831
• 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: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2026

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: 330231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 04/27/2026; 06/17/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/18/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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