MAUDE Adverse Event Report: Ivantis, Inc. (subsidiary of Alcon Research, LLC) HYDRUS MICROSTENT; Intraocular Pressure Lowering Implant

Catalog Number	100300293
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Adhesion(s) (1695); Eye Injury (1845); Inflammation (1932)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported via a clinical study that a patient experienced iris inlet adhesions in the left eye following stent implantation.Follow-up information clarified that the event was associated with partial stent-iris touch and intraocular inflammation.Medical treatment was administered, and the inflammation resolved; however, the iris adhesion (synechiae) persisted and could remain unless surgically lysed, although surgical intervention was not considered necessary.The reporter noted no change in intraocular pressure (iop) and a stable stent, and ongoing monitoring was planned.Iris inlet adhesions, partial stent-iris touch and associated intraocular inflammation were considered related to the stent and not related to the stent implantation procedure or the cataract procedure.No secondary ocular surgical intervention was performed.The inflammation resolved following treatment, while the adhesion/synechiae remained under observation.Onset severity of the inflammation reported as mild.
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).

• Brand Name: HYDRUS MICROSTENT
• Common Device Name: Intraocular Pressure Lowering Implant
• Manufacturer (Section D): Ivantis, Inc. (subsidiary of Alcon Research, LLC); 201 technology drive; irvine CA 92618
• Manufacturer (Section G): Ivantis, Inc. (subsidiary of Alcon Research, LLC); 201 technology drive; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50838305
• Report Number: 3016075957-2026-00097
• Device Sequence Number: 16021857
• Product Code: OGO
• UDI-Device Identifier: 00867487000134
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 11/01/2025
• Device Catalogue Number: 100300293
• Device Lot Number: 23900338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 11/01/2023
• 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.; Swan Jacob gonioprism used.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown