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	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during attempt to implant the first stent of two (2) stents from a trabecular microbypass stent system, the trocar "came out from the insertion tube".Per report, the surgeon initially thought that the stent was successfully implanted with the first deployment, however when the injector was removed from the trabecular meshwork (tm), both the trocar and insertion tube remained in the (tm).Per report, the surgeon was able to intraoperatively remove the trocar and the two (2) stents in the trocar tip, with no adverse patient impact and minimal bleeding.The report noted that the procedure was completed using a back-up device, with two stents successfully implanted.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
Additional information: a1, a2, a3, b5, b6, g2, g3.A6: race noted as japanese.A review of the surgical video was completed, and the reported issue of a trocar dislodged from the insertion tube was observed.However, any conclusions based solely on the surgical video could not be made.Mfr# reference: (b)(4).
Event or Problem Description
Through follow-up, the following additional information was received.Per report, there was no adverse patient impact or intervention required (os) with the patient's current status reported as "no problems after surgery".
Additional Manufacturer Narrative
Additional information: g2, g3, h3.The device was returned nested in the thermoform packaging tray, and the trocar was returned in a separate bag with two (2) stents located on the trocar.The device evaluation was completed and the trocar was found removed from the device.There were no nonconformances found with the remainder of the frontal components.The customer¿s reported issue was confirmed and the retention finger was observed to be deformed.Based on the device evaluation findings, the root cause of the deformed retention finger was not conclusively identified.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: 23385281
• Report Number: 2032546-2025-00108
• Device Sequence Number: 9057040
• Product Code: OGO
• UDI-Device Identifier: 00853704002487
• UDI-Public: 01008537040024871032596017270430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2026

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: 325960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 12/29/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/19/2025; 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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: 74 YR
• Patient Sex: Male
• Patient Race: Asian