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

Catalog Number	100300293
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during a trabecular stent implantation procedure, the stent did not deploy.Additional information was requested but no information is available at the time of this report.
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: 50897322
• Report Number: 3016075957-2026-00099
• Device Sequence Number: 10684181
• Product Code: OGO
• UDI-Device Identifier: 00867487000134
• UDI-Public: (01)00867487000134(17)270731(11)250822(10)17LYY5
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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 Catalogue Number: 100300293
• Device Lot Number: 17LYY5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 08/22/2025
• 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 Sex: Unknown