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

Model Number	G2-W-US
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trocar broke during a trabecular microbypass stent system procedure, and the fragment was observed in the angle.Per report, the surgeon believes the fragment was successfully removed intraoperatively from the patient's eye during irrigation and aspiration with no report of adverse patient impact.Reportedly, the procedure was completed using a back-up device.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: the device was not available; therefore, product testing on the actual device could not be performed the device identifiers were not provided; therefore, the device history records for this device lot number could not be reviewed.The device identifiers were not provided; therefore, a complaint history review for this device lot number could not be completed.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
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 #.The device was returned loose in the unit carton package, and no stents were returned.The device evaluation was completed, and the trocar was found broken off at the splay.This finding likely occurred during the surgical procedure, due to a heavily bias trocar causing the stent to collide with the trocar.Additionally, deformation was observed on the insertion tube, which likely occurred due to the way the device was shipped back.Conclusions based on the evaluation findings were confounded by the condition of the returned product.As a result, the root cause of the reported issue was not conclusively identified.Mfr# reference: (b)(4).

• Brand Name: ISTENT INJECT W TRABECULAR MICRO-BYPASS SYSTEM
• 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: 23688450
• Report Number: 2032546-2025-00124
• Device Sequence Number: 12244346
• Product Code: OGO
• UDI-Device Identifier: 00853704002319
• UDI-Public: 01008537040023191033029017280731
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: G2-W-US
• Device Lot Number: 330290
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2025
• 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