Terumo NF-3013RBKE05MRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05413206251223), received between May 14, 2025 and Jun 1, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THERE WAS A CASE WITH A SERIOUS BLINDING ISSUE. THEY DID NOT USE THE MEDICATION ON THE PATIENT. THE PROCEDURE OUTCOME IS UNKNOWN. THE FINAL PATIENT IMPACT IS UNKNOWN.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25356415 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THERE WAS A CASE WITH A SERIOUS BLINDING ISSUE. THEY DID NOT USE THE MEDICATION ON THE PATIENT. THE PROCEDURE OUTCOME IS UNKNOWN. THE FINAL PATIENT IMPACT IS UNKNOWN.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25356414 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25115903 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  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 OUT 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.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25115902 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PATIENT HAD A SERIOUS BLINDING ISSUE REGARDING THE VABYSMO PFS.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25112597 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PATIENT HAD A SERIOUS BLINDING ISSUE REGARDING THE VABYSMO PFS.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25102817 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PATIENT RECEIVED VABYSMO INJECTIONS IN BOTH EYES AND SUBSEQUENTLY DEVELOPED BILATERAL UVEITIS IN BOTH EYES. THE DOCTOR HAD A LOT OF EXPERIENCE WITH THIS PRODUCT, AND IT WAS THE FIRST TIME HE ENCOUNTERED SOMETHING LIKE THIS. THE PHARMACIST CONFIRMED THAT THE PRODUCT USED WAS STORED AT A TEMPERATURE OF 2-8°C. THERE WERE NO TEMPERATURE DEVIATIONS. THE FINAL PATIENT IMPACT WAS UNKNOWN.

  Patient problems: Uveitis

  MAUDE report 24701780 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PATIENT WAS HOSPITALIZED FOLLOWING THE INJECTION DUE TO UVEITIS. UPON CLINICAL REVIEW, THE INFLAMMATION WAS FOUND TO BE VERY MILD AND WAS MANAGED SOLELY WITH EYE DROPS. HOWEVER, HOSPITALIZATION WAS REQUIRED TO RULE OUT ENDOPHTHALMITIS. THE DOCTOR HAD A LOT OF EXPERIENCE WITH THIS PRODUCT, AND IT IS THE FIRST TIME HE ENCOUNTERS SOMETHING LIKE THIS. THE PHARMACIST CONFIRMED THAT THE PRODUCT WAS STORED AT A TEMPERATURE OF 2-8°C. THERE WERE NO TEMPERATURE DEVIATIONS. THE FINAL PATIENT IMPACT WAS UNKNOWN.

  Patient problems: Uveitis

  MAUDE report 24701779 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PATIENT WAS HOSPITALIZED FOLLOWING THE INJECTION DUE TO UVEITIS. UPON CLINICAL REVIEW, THE INFLAMMATION WAS FOUND TO BE VERY MILD AND WAS MANAGED SOLELY WITH EYE DROPS. HOWEVER, HOSPITALIZATION WAS REQUIRED TO RULE OUT ENDOPHTHALMITIS. THE DOCTOR HAD A LOT OF EXPERIENCE WITH THIS PRODUCT, AND IT IS THE FIRST TIME HE ENCOUNTERS SOMETHING LIKE THIS. THE PHARMACIST CONFIRMED THAT THE PRODUCT WAS STORED AT A TEMPERATURE OF 2-8°C. THERE WERE NO TEMPERATURE DEVIATIONS. THE FINAL PATIENT IMPACT WAS UNKNOWN.

  Patient problems: Uveitis

  MAUDE report 24701778 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE COMPLAINT AFFECTS FILTER NEEDLES CO-PACKED WITH VABYSMO. CIOMS FORM RECEIVED FROM ROCHE GLOBAL WITH RELATED CAUSALITIES: BLIND; SUSPECTED TRANSMISSION OF INFECTIOUS AGENTS VIA MEDICINAL PRODUCT. THE PROCEDURE OUTCOME AND FINAL PATIENT IMPACT ARE BOTH UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 07JAN2026: IT CONCERNS A PATIENT OF UNKNOWN DEMOGRAPHICS (HEIGHT, WEIGHT AND PATIENT NUMBER NOT REPORTED (B)(6) WHO DEVELOPED SUSPECTED TRANSMISSION OF INFECTIOUS AGENTS VIA A MEDICINAL PRODUCT AND BECAME BLIND IN BOTH EYES (BILATERAL BLINDNESS) WHILST PARTICIPATED IN NIP-US-1400, ACCESS SOLUTIONS WHILE BEING TREATED WITH FARICIMAB (VABYSMO). NO MEDICAL HISTORY, PAST PRODUCTS, CONCURRENT CONDITIONS OR CONCOMITANT PRODUCTS WERE REPORTED. ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH INTRAVITREAL SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE FARICIMAB 6 MG FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED SUSPECTED TRANSMISSION OF INFECTIOUS AGENTS VIA A MEDICINAL PRODUCT AND BECAME BLIND IN BOTH EYES (BILATERAL BLINDNESS) AFTER THE 2ND BILATERAL EYE TREATMENT WITH VABYSMO PREFILLED SYRINGE IN THE HCP

  Patient problems: Loss of Vision

  MAUDE report 24090311 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE COMPLAINT AFFECTS FILTER NEEDLES CO-PACKED WITH VABYSMO. THE DOCTOR HAD CONCERNS REGARDING THE QUALITY OF VABYSMO PFS. THE DEVICE WAS INVOLVED IN AN IOI CASE. THE DOCTOR HAD NOT REPORTED ANY SPECIFIC PRODUCT QUALITY DEFICIENCY. THE PROCEDURE OUTCOME WAS FINAL PATIENT IMPACT WERE UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 06JAN2026: IOI IS INTRA-OCULAR INFLAMMATION. IN PARTICULAR, THE PATIENT EXPERIENCED AN UVEITIS. BELOW IS THE EXTRACT OF THE MEDICAL REPORT: ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE FARICIMAB FOR DIABETIC MACULAR OEDEMA (DMO) EVERY MONTH, IN LEFT EYE TREATMENT WAS ADMINISTERED WITH THE NEEDLE INCLUDED IN THE PACKAGE AND PFS WAS USED FROM THE START WITHOUT PRIOR VIAL USE. DATE OF LAST DOSE PRIOR TO ADVERSE EVENT (AE) ONSET WAS NOT REPORTED. ON AN UNKNOWN DATE, IT WAS REPORTED THAT, SHE HAD FIRST 3 DOSES ON A MONTHLY SCHEDULE, SHE ATTENDED THE CLINIC TO RECEIVE THE 3RD DOSE, DURING THE REVIEW, BEFORE THE ADMINISTRATION OF THE 3RD DOSE, SHE REPORTED THAT SHE EXPERIENCED VISION LOSS AFTER THE ADMINISTRATION OF THE 2ND DOSE ONE MONTH AGO, TOTAL

  Patient problems: Loss of Vision; Uveitis

  MAUDE report 24053285 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE COMPLAINT AFFECTS FILTER NEEDLES CO-PACKED WITH VABYSMO. A DOCTOR, FROM THE SPANISH HOSPITAL, REPORTED TO OUR LOCAL APS DEPARTMENT THAT HE HAS CONCERNS ABOUT THE QUALITY OF VABYSMO PFS. THE DOCTOR REQUESTS ROCHE TO INVESTIGATE ANY POTENTIAL PRODUCT QUALITY DEFICIENCIES THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. THE DOCTOR HAS NOT REPORTED ANY SPECIFIC PRODUCT QUALITY DEFICIENCY. THE PATIENT HAD VITRITIS, PANUVEITIS AND UVEITIS. THE PROCEDURE OUTCOME IS UNKNOWN.

  Patient problems: Inflammation; Uveitis; Vitritis

  MAUDE report 23888159 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE COMPLAINT AFFECTS FILTER NEEDLES CO-PACKED WITH VABYSMO. A DOCTOR, FROM THE SPANISH HOSPITAL, REPORTED TO OUR LOCAL APS DEPARTMENT THAT HE HAS CONCERNS ABOUT THE QUALITY OF VABYSMO PFS. THE DOCTOR REQUESTS ROCHE TO INVESTIGATE ANY POTENTIAL PRODUCT QUALITY DEFICIENCIES THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. THE DOCTOR HAS NOT REPORTED ANY SPECIFIC PRODUCT QUALITY DEFICIENCY. THE PATIENT HAD PANUVEITIS AND IS RECOVERING/RESOLVING. THE PROCEDURE OUTCOME IS UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 23888158 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE COMPLAINT AFFECTS FILTER NEEDLES CO-PACKED WITH VABYSMO. A DOCTOR, FROM THE SPANISH HOSPITAL, REPORTED TO OUR LOCAL APS DEPARTMENT THAT HE HAS CONCERNS ABOUT THE QUALITY OF VABYSMO PFS. THE DOCTOR REQUESTS ROCHE TO INVESTIGATE ANY POTENTIAL PRODUCT QUALITY DEFICIENCIES THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. THE DOCTOR HAS NOT REPORTED ANY SPECIFIC PRODUCT QUALITY DEFICIENCY. THE PATIENT HAD VITRITIS, PANUVEITIS AND IS RECOVERING/RESOLVING. THE PROCEDURE OUTCOME IS UNKNOWN.

  Patient problems: Inflammation; Vitritis

  MAUDE report 23888157 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE COMPLAINT AFFECTS FILTER NEEDLES CO-PACKED WITH VABYSMO. A DOCTOR, FROM THE SPANISH HOSPITAL, REPORTED TO OUR LOCAL APS DEPARTMENT THAT HE HAS CONCERNS ABOUT THE QUALITY OF VABYSMO PFS. THE DOCTOR REQUESTS ROCHE TO INVESTIGATE ANY POTENTIAL PRODUCT QUALITY DEFICIENCIES THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. THE DOCTOR HAS NOT REPORTED ANY SPECIFIC PRODUCT QUALITY DEFICIENCY. THE PATIENT HAD VITRITIS AND IS RECOVERING/RESOLVING. THE PROCEDURE OUTCOME IS UNKNOWN.

  Patient problems: Vitritis

  MAUDE report 23888156 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  THE USER FACILITY REPORTED THAT THE COMPLAINT INVOLVES FILTER NEEDLES CO-PACKED WITH VABYSMO. A PATIENT DEVELOPED A BACTERIAL EYE INFECTION FIVE DAYS AFTER RECEIVING THE MEDICATION. THE INFECTION REQUIRED SURGICAL TREATMENT AT AN OPHTHALMOLOGY CLINIC. THE REPORTING CLINIC INDICATED THAT THE INFECTION MAY HAVE BEEN ASSOCIATED WITH THE MEDICATION. THE CASE WAS FORWARDED FROM THE DRUG COMMISSION OF THE GERMAN MEDICAL ASSOCIATION (AMK) TO THE REGIONAL COUNCIL TÜBINGEN (RP TÜBINGEN). THE INFECTION OCCURRED FOLLOWING THE MOST RECENT INJECTION; THE PREVIOUS NINE INJECTIONS WERE WELL TOLERATED, INCLUDING TWO PRE-FILLED SYRINGES. THE FIRST INJECTION IN (B)(6) 2024 AND ONE OF THE PRE-FILLED SYRINGES WERE FROM DIFFERENT BATCHES. THE PATIENT WAS HOSPITALIZED FOR ONE WEEK FOLLOWING SURGICAL TREATMENT. THE PATIENT WAS BEING TREATED FOR WET MACULAR DEGENERATION. THE EVENT OCCURRED POST-TREATMENT. SURGICAL INTERVENTION WAS REQUIRED. THE FINAL PATIENT IMPACT WAS PARTIAL RECOVERY; IMPROVEMENT WAS NOTED, BUT FULL RECOVERY HAD NOT YET OCCURRED.

  Patient problems: Endophthalmitis; Intraocular Infection

  MAUDE report 22801212 ↗
• InjuryMay 14, 2025Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  THE USER FACILITY REPORTED THAT THE COMPLAINT AFFECTS FILTER NEEDLES CO-PACKED WITH VABYSMO. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED ENDOPHTHALMITIS, SUSPECTED TO BE DUE TO THE TRANSMISSION OF AN INFECTIOUS AGENT VIA THE MEDICINAL PRODUCT. THE REPORTER ASSESSED THE SUSPECTED TRANSMISSION OF THE INFECTIOUS AGENT AS RELATED TO VABYSMO. THE COMPANY ALSO ASSESSED THE CAUSALITY OF ENDOPHTHALMITIS AS RELATED TO VABYSMO. THE EVENT OCCURRED POST-TREATMENT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED, AND NO HARM WAS REPORTED.

  Patient problems: Endophthalmitis

  MAUDE report 22023062 ↗
• InjuryMay 14, 2025Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  THE USER FACILITY REPORTED THAT THE COMPLAINT AFFECTS FILTER NEEDLES CO-PACKED WITH VABYSMO. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED ENDOPHTHALMITIS, SUSPECTED TO BE DUE TO THE TRANSMISSION OF AN INFECTIOUS AGENT VIA THE MEDICINAL PRODUCT. THE REPORTER ASSESSED THE SUSPECTED TRANSMISSION OF THE INFECTIOUS AGENT AS RELATED TO VABYSMO. THE COMPANY ALSO ASSESSED THE CAUSALITY OF ENDOPHTHALMITIS AS RELATED TO VABYSMO. THE EVENT OCCURRED POST-TREATMENT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED, AND NO HARM WAS REPORTED.

  Patient problems: Endophthalmitis

  MAUDE report 22022808 ↗