MAUDE Adverse Event Report: Glaukos Corporation iStent Infinite Trabecular Micro-Bypass System; Aqueous Shunt

Model Number	iS3-BR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Through follow-up, the following additional information was received.Per report, the surgeon confirmed that the trocar was initially observed to be bent while inside the anterior chamber, and was subsequently removed from the eye without being activated.Reportedly, the surgeon touched the bent trocar with forceps outside of the eye, and the trocar then broke with no possibility of any fragment remaining in the eye.
Additional Manufacturer Narrative
Additional information: b5, g2, g3.The additional information received through follow-up was reassessed for reportability criteria; and concluded that the reported event no longer meets the statutory definition of a medical device reportable event.Based on the clarification received, glaukos no longer considers this report as a reportable event.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: 50870021
• Report Number: 2032546-2026-00086
• Device Sequence Number: 16117566
• Product Code: KYF
• UDI-Device Identifier: 00853704002470
• UDI-Public: 0100853704002470103311971727093021331197BR0061
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: iS3-BR
• Device Lot Number: 331197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2025
• 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: 54 YR
• Patient Sex: Male
• Patient Race: White