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

Catalog Number	100300293
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Intraocular Pressure Increased (1937); Uveitis (2122); Blurred Vision (2137)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that during the post operative week one visit after the stent implantation procedure, the patient experienced blurry vision and floaters since post operative day 5.The patient had diffuse granulomatous keratic precipitates (kps), anterior chamber and vitreous cell.The physician did tap and inject just to be safe, but conjunctiva was white and quiet, no pain, didn¿t really seem like endophthalmitis.The physician thought it could be early sympathetic ophthalmia or reaction to stent (granulomatous inflammatory reaction).Additional information was requested and received stating post-operatively, granulomatous uveitis was first noted on post-operative day 8, accompanied by worsened vision and elevated intraocular pressure.Given the presentation of anterior chamber and vitreous cell within one week of surgery, the condition had initially been treated as a possible case of post-operative endophthalmitis.The patient underwent a vitreous tap and received an intravitreal injection of cephalosporin antibiotics and glycopeptide antibiotics on the same day.The patient had been last seen on post operative day 14 (last seen date), at which point bacterial cultures and viral pcr from the vitreous fluid had been negative, ruling out infectious endophthalmitis and herpetic infection.The clinical condition had shown improvement with frequent topical steroid use, and the inflammation was expected to continue resolving.Post-operative medications had included corticosteroids, quinolone antibiotics, nonsteroidal anti-inflammatory drugs, cephalosporin antibiotics, and glycopeptide antibiotics.
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
A sample was not received at the investigation site for evaluation for the report of granulomatous inflammatory reaction, blurry vision, floaters, and intraocular pressure increase; 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).

• 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: 21596918
• Report Number: 3016075957-2025-00014
• Device Sequence Number: 8878071
• Product Code: OGO
• UDI-Device Identifier: 00867487000134
• UDI-Public: (01)00867487000134(17)260826(11)240826(10)24800017
• 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
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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: 08/26/2026
• Device Catalogue Number: 100300293
• Device Lot Number: 24800017
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 06/10/2025
• Date Device Manufactured: 08/26/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AND THE FOLLOWING DAY, VALTREX 500 MG TID ADDED; CIPROLFOXACIN QID,; KETOROLAC QID; PREDNISOLONE INCREASED TO Q1H.; PREDNISOLONE QID,; S/P INTRAVITREAL INJECTION OF CETAZIDIME; S/P INTRAVITREAL INJECTION OF VANCOMYCIN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American