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

Model Number	IS3-WW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: the device was not available; 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 was completed.Decreased/impaired vision is identified in the labeling 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.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.Decreased/impaired vision is an established risk associated with use of the device, which is clearly specified in the product's labeling.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 one (1) month postop following a left eye (os) trabecular microbypass stent system procedure, the patient presented with decreased best spectacle corrected visual acuity (bscva), noted at thirty-seven (37) letters.The report described the event as "mild and non-serious" with a loss of two (2) lines from baseline.Per report, the patient is recovering with no intervention required.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, b6, g2, g3.Mfr# reference: (b)(4).
Event or Problem Description
The following additional information was received.Per report, the patient presented six (6) months postop with visual field loss "greater than 2.5 db" in the left eye (os), which was described as "mild" and "non-serious" and did not require intervention.The report noted the event resolved approximately one (1) month later.
Event or Problem Description
The following additional information was received.Per report, the patient presented with best spectacle corrected visual acuity (bscva) decrease during the twenty-four (24) month postoperative examination, which was noted as "moderate" and "non-serious" with no intervention, and the event unresolved.
Additional Manufacturer Narrative
Additional information: b5, b6, g2, g3.Mfr# reference: (b)(4).

• 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 ; +1(949)367-9600
• MDR Report Key: 19609423
• Report Number: 2032546-2024-00067
• Device Sequence Number: 15474874
• Product Code: KYF
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2026

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: 09/30/2025
• Device Model Number: IS3-WW
• Device Lot Number: 315522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 01/28/2025; 08/31/2026
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 02/05/2025; 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2023
• 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: 77 YR
• Patient Sex: Male
• Patient Race: White