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	Loss of Vision (2139); Insufficient Information (4580)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported via study that after the implantation of the microstent, malposition of the microstent was noticed and it was noted to be mild.The stent was repositioned.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
A sample was not received at investigation site for evaluation for the report of patient with microstent malposition and repositioning; 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; therefore, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was added in b.2., b.3., b.5., b.6.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information stated that worsening of visual field (mean deviation greater than or equal to 2.5 decibels (db) or more confirmed by 2 repeat measurements).

• 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: 20810726
• Report Number: 3016075957-2024-00056
• Device Sequence Number: 18455281
• Product Code: OGO
• UDI-Device Identifier: 00867487000134
• UDI-Public: (01)00867487000134(17)251121(11)231121(10)23900339(21)NA
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 04/23/2025

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: 11/21/2025
• Device Catalogue Number: 100300293
• Device Lot Number: 23900339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 02/06/2025; 04/03/2025
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 03/03/2025; 04/23/2025
• Date Device Manufactured: 11/21/2023
• 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: ACRYSOF IQ TORIC SINGLEPIECE IOL.; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown