MAUDE Adverse Event Report: TERUMO EUROPE N.V TERUMO INJECTION FILTER NEEDLE; OPHTHALMIC NEEDLE

Model Number	NF-3013RBKE05M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo received the following information: healthcare professional reported bilateral sterile endophthalmitis and vasculitis after vabysmo, pfs 6mg, (lotb7005b09, exp date: 30apr2026) intravitreal injection on (b)(6) 2025.Patient had been receiving this drug without incident for about nine months.In the weeks following (b)(6) 2025, she reported decline in vision ou with floaters.When she presented on (b)(6) 2025, she had bilateral dense endophthalmitis.Vitrectomy with vitreous biopsy was performed on one eye with injection of broad-spectrum antibiotics.Intraoperative view showed vasculitis.Decline in vision in both eyes (ou) with floaters, bilateral dense endophthalmitis.Vitrectomy with vitreous biopsy was performed on one eye with injection of broad-spectrum antibiotics.Intraoperative view showed vasculitis.

• Brand Name: TERUMO INJECTION FILTER NEEDLE
• Common Device Name: OPHTHALMIC NEEDLE
• Manufacturer (Section D): TERUMO EUROPE N.V; interleuvenlaan 40; leuven, vlaams brabant 3001 ; BE 3001
• MDR Report Key: 25115903
• Report Number: 2243441-2026-00021
• Device Sequence Number: 18700049
• Product Code: QYM
• UDI-Device Identifier: 05413206251223
• UDI-Public: 05413206251223
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026
• Report Date (Section F): 05/07/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: NF-3013RBKE05M
• Device Catalogue Number: NF-3013RBKE05M
• Device Lot Number: 2407010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/09/2026
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYRINGE (FOR PRODUCT VABYSMO)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/07/2026