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

Model Number	IS2-JP
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: type of investigation 5: b21.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 and associated risk documents was completed.Particulate/foreign matter is identified as a known inherent risk of trabecular micro-bypass stent procedure.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.There does not appear to have been a problem with the device or the way it was used.Particulate/foreign matter is an established risk associated with use of the device, which is clearly specified documented.Based on the information received, the root cause of the reported event could not be conclusively identified.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that in conjunction with left eye (os) cataract surgery followed by the implantation of the first stent (of two stents) from a trabecular microbypass stent system, the surgeon observed intraoperatively what appeared to be a "fibrous-like material" and "white fibers" after the trocar was removed from the patient's eye.Subsequently following the implantation of the second stent, the same "fibrous-like material" was observed in the anterior chamber (ac).The report noted that the causal relationship between the fibrous material is unknown.There was no report of any adverse patient impact.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, b6, b7, g2, g3.A6: patient race noted as japanese.Correction: d1.A review of the surgical video was completed, and the reported fibrous-like material was observed.However, due to poor video quality, a conclusion based 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, the origin of the fibrous material is unknown, however since it was observed during the first stent deployment, the surgeon believes it originated from the internal part of the device.Reportedly, there was no adverse patient impact or additional treatment required.The report noted the patient status as "good progress" with the event "resolved".
Additional Manufacturer Narrative
Additional information: g2, g3, h3.The injector was returned nested in the unsealed thermoform packaging tray.The device evaluation was completed and no non-conformances were found.Based on the evaluation findings, the root cause of the reported issue 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 CORPORTATION; 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: 21986131
• Report Number: 2032546-2025-00057
• Device Sequence Number: 4618434
• 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
• 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): 07/01/2025

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: 05/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 06/27/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 05/19/2025; 07/01/2025
• 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 Age: 85 YR
• Patient Sex: Male
• Patient Race: Asian