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

Catalog Number	100300293
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Visual Impairment (2138)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported through a clinical study site that a patient developed an eight-ball hyphema with elevated intraocular pressure on postoperative day one following a stent implantation procedure.To prevent corneal blood staining, the patient was taken to the operating room the same day, and an anterior chamber washout was immediately performed.At follow up day after the washout, the patient had persistent poor vision but showed a much improved degree of hyphema.The patient¿s vision subsequently improved.
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).
Additional Manufacturer Narrative
Additional information was added in h.3., h.6.And h.11.A sample was not received at the investigation site for evaluation for the report of repositioning, elevated intraocular pressure, anterior chamber washout, poor vision; 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.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: 23004310
• Report Number: 3016075957-2025-00045
• Device Sequence Number: 9413586
• Product Code: OGO
• UDI-Device Identifier: 00867487000134
• UDI-Public: (01)00867487000134(17)250829(11)230829(10)24800003
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 08/29/2025
• Device Catalogue Number: 100300293
• Device Lot Number: 24800003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 08/29/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown