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 Codes	Cataract (1766); Iritis (1940)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Iritis identified in the labeling as known inherent risk of trabecular micro-bypass aqueous shunt procedure.The ifu adequately provides instructions, 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 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 following an istent infinite trabecular microbypass system procedure, the patient presented one (1) week postoperatively with mild iritis associated with 1+ cell noted in the anterior chamber, which was treated with medication.The report noted the event as ongoing.Additional information has been requested.
Event or Problem Description
The following additional information was received.Per report, the patient presented with mild transillumination of mid periphery and mild cortical changes of the lens occurring on (b)(6) 2022.The investigator indicated both ongoing events as non-serious.There was no report of any interventions required.
Additional Manufacturer Narrative
Mfr# reference: (b)(4).
Additional Manufacturer Narrative
Additional information: b5, b6, g3, g4.Mfr# reference: (b)(4).
Event or Problem Description
Through follow-up, the following information was provided.The patient''s most recent examination noted no further interventions required.

• 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: 15559729
• Report Number: 2032546-2022-00110
• Device Sequence Number: 7073711
• Product Code: KYF
• UDI-Device Identifier: 00853704002470
• UDI-Public: 0100853704002470
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220032
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2023

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: 08/31/2023
• Device Model Number: IS3-WW
• Device Lot Number: 112718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 11/04/2022; 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female