MAUDE Adverse Event Report: IVANTIS INC HYDRUS MICROSTENT; INTRAOCULAR PRESSURE LOWERING IMPLANT

Catalog Number	100300293
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Hyphema (1911); Intraocular Pressure Increased (1937); Uveitis (2122)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional had reported after trabecular stent implantation surgery patient had choroidal folds.Blood in the chamber had prohibited visualization, and additional postoperative checks were performed.Intraocular pressure had spiked but was later controlled with drops.The choroidal folds had resolved.The stent had dived.No heme had been observed.The symptoms were resolved.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.A sample was not received at the investigation site for evaluation for the report of choroidal folds after stent implant, stent did dive, pressure had spiked, and blood in chamber prohibited visualization; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The investigation conducted a non-conformance review of the reported lot number.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information and materials received, the investigation was unable to identify the root cause or origin of the reported event.While the root cause and its origin are inconclusive, the following factors outlined in the reported product¿s ifu (instruction for use) could potentially contribute to an outcome similar to the reported event.Hyphema obscuring the surgeon¿s view is a potential intraoperative adverse effect outlined in the system's ifu and micro stent malposition, dislodgement, or movement, and elevated iop (intraocular pressure) requiring treatment with oral or intravenous medications or with surgical intervention are noted as potential postoperative adverse events associated with use of the hydrus system that are clearly specified in the product ifu.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.All stent delivery systems are 100% visually and functionally inspected prior to being released from the manufacturing facility.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.The manufacturer internal reference number is: (b)(4).

• Brand Name: HYDRUS MICROSTENT
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): IVANTIS INC; 201 technology drive; irvine CA 92618
• Manufacturer (Section G): IVANTIS INC; 201 technology drive; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23715047
• Report Number: 3016075957-2025-00068
• Device Sequence Number: 8845458
• Product Code: OGO
• UDI-Device Identifier: 00867487000134
• UDI-Public: (01)00867487000134(17)260813(11)240813(10)24800015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2026
• Device Catalogue Number: 100300293
• Device Lot Number: 24800015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 08/13/2024
• 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: 71 YR
• Patient Sex: Male