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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: type of investigation 5: b15.The device has been returned to glaukos for evaluation, and the investigation is ongoing.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 issue) 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.A review of the surgical video was performed, and the customer¿s reported issue was observed.Per the video, it appears that the surgeon was able to successfully remove the trocar in its entirety (with the two stents) using forceps.Based on the investigation and the available information, the root cause of the reported issue could not be conclusively identified.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that during an attempt to implant the first stent from a trabecular microbypass stent system, the trocar "was coming out" of the injector when the delivery button was pressed.Per report, a back-up device was used to complete the procedure with two (2) stents implanted in the patient's eye and no report of injury or postoperative complications.Additional information has been requested.
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.Reportedly, there was no adverse patient impact or intervention required in the left eye (os).The report also noted "a normal stent procedure" and "there was nothing particularly notable" about the patient's condition.
Additional Manufacturer Narrative
Additional information: g2, g3, h3.The device was returned nested in the unsealed thermoform packaging tray.The device evaluation was completed, and the retention finger was observed to be deformed and was not functioning properly.The customer¿s reported issue was confirmed; however, based on these 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: 22178688
• Report Number: 2032546-2025-00061
• Device Sequence Number: 8669575
• Product Code: OGO
• UDI-Device Identifier: 00853704002487
• UDI-Public: 01008537040024871032351217261031
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2025

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: 323512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 07/15/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/01/2025; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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