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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Vitreous Detachment (2445)
Date of Event	01/05/2025
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.Decreased/impaired vision and posterior vitreous detachment are identified as 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 events are established risks associated with use of the device, which is clearly documented.Based on the information received, the root cause of the reported events could not be conclusively identified.Mfr# reference: (b)(4).Please reference report 2032546-2025-00024 for the report of blurred visual acuity associated with the right eye (od).
Event or Problem Description
It was reported that following bilateral trabecular microbypass stent procedures, the patient presented postoperatively with intermittent blurred visual acuity (ou), described as "severe" and "non-serious", with the episode of blurred vision lasting a few seconds before resolving.Per report, the patient was referred to a retina specialist and to cardiology, and the results are pending.Additionally per report, the patient presented with posterior vitreous degeneration in the left eye (os), which was described as "mild" and "non-serious" with no reported intervention.Additional information has been requested.This report references the case of blurred visual acuity and posterior vitreous degeneration associated with the left eye (os).

• 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: 21406773
• Report Number: 2032546-2025-00023
• Device Sequence Number: 18487256
• Product Code: OGO
• UDI-Device Identifier: 00853704002319
• UDI-Public: 01008537040023191030113317241031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2025

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 Expiration Date: 10/31/2024
• Device Model Number: G2-W-US
• Device Lot Number: 301133
• 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: 01/30/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2021
• 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: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American