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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Fibrosis (3167); Eye Pain (4467)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: the device remains implanted in the patient; therefore, product testing on the actual device could not be performed.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 review of the device labeling and associated risk documents was completed.Pain, inflammation and decreased/impaired vision are identified in the labeling as a known inherent risks 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.An adverse event appears to have occurred but does not appear to have been a problem with the device or the way it was used.The reported event (fibrin, pain and decreased/impaired vision) are established risks associated with use of the device, which is clearly 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 following an uneventful right eye (od) cataract plus trabecular microbypass stent system procedure, the patient presented on postoperative day one (1) with fibrin formation and pain.Per report, an anterior chamber washout was performed the same day, and the anterior chamber appeared clear that evening.Reportedly, the following morning fibrin was again observed, which was treated with medication and resolved the same day.Through follow-up, the following additional information was received.Per report, a culture test was performed which was negative for bacterial growth, and a postoperative fundus examination indicated a prior history of sarcoidosis and a possible excessive immune response.Reportedly, the fibrinous reaction resulted in decreased visual acuity likely due to pigment adherence to the intraocular lens from recent inflammation, and fibrin adhesion on the toric lens causing displacement from its proper position.The report noted that the patient's intraocular pressure is stable with no further intervention.
Additional Manufacturer Narrative
Additional information: b1.A review of the surgical video and imaging was completed, and a strand of whitish-gray material extending from the cornea to the iris was identified.However, it could not be determined if the material was fibrin or retained lens matter from the cataract surgery.Additionally, operator technique causing an inflammatory response may have been a contributing factor.Based on the investigation, the available media and information, the root cause of the reported event could not be conclusively determined.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: 23065849
• Report Number: 2032546-2025-00093
• Device Sequence Number: 9849859
• 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
• 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
• Report Date (Section B): 09/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IS2-JP
• Device Lot Number: 325960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 31 YR
• Patient Sex: Female