MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT INFINITE TRABECULAR MICRO-BYPASS SYSTEM; AQUEOUS SHUNT

Model Number	IS3-US
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: the device is expected to be returned for evaluation but has not been received at glaukos evaluation center.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 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 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.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 (particulate/foreign matter) is an established risk 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).Please reference report 2032546-2025-00009 for the report of particulate/foreign matter associated with device two (2) of two (2).
Event or Problem Description
It was reported that during a trabecular microbypass stent system procedure, the surgeon observed "black spots" within the sterile packaging of two (2) unopened devices.Reportedly, an additional device was used to complete the procedure.Per report, the devices were unopened/unused, and there was no patient contact.Additional information has been requested.This report references the report of particulate/foreign matter associated with device one (1) of two (2).
Additional Manufacturer Narrative
Additional information: d9, g2, g3, h3.The device was returned for evaluation.The tyvek seal was unsealed from the thermoform packaging tray.No particulate was found during visual inspection of the returned items.Based on these findings, the root cause of the customer¿s reported issue was not conclusively identified.Mfr # reference: (b)(4).Please reference report 2032546-2025-00009 for the report of particulate/foreign matter associated with device two (2) of two (2).

• Brand Name: ISTENT INFINITE TRABECULAR MICRO-BYPASS SYSTEM
• Common Device Name: AQUEOUS SHUNT
• 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: 21232448
• Report Number: 2032546-2025-00008
• Device Sequence Number: 4287263
• Product Code: KYF
• UDI-Device Identifier: 00853704002449
• UDI-Public: 01008537040024491032345317260930
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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 Expiration Date: 09/30/2026
• Device Model Number: IS3-US
• Device Lot Number: 323453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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