NEEDLE FILTER BLUNT FILL 18X1-1/2

Description of Event or Problem

IT WAS REPORTED, NEEDLE FILTER BLUNT FILL 18X1-1/2, MULTIPLE CASES OF INFECTIOUS ENDOPHTHALMITIS FOLLOWING INTRAVITREAL ADMINISTRATION OF AFLIBERCEPT (EYLIA). PATIENT 1 OF 5. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: I HEREBY FORMALLY REPORT THE OCCURRENCE OF MULTIPLE CASES OF INFECTIOUS ENDOPHTHALMITIS FOLLOWING INTRAVITREAL INJECTIONS OF AFLIBERCEPT (EYLIA), PERFORMED AT A PUBLIC OPHTHALMOLOGY SERVICE IN THE STATE OF (B)(6) ON (B)(6) 2026, EIGHT (8) INTRAVITREAL INJECTIONS OF AN ANTI-VEGF AGENT (EYLIA ¿ AFLIBERCEPT) WERE ADMINISTERED TO SIX (6) PATIENTS, TOTALING EIGHT (8) TREATED EYES. CLINICAL INDICATIONS INCLUDED DIABETIC MACULAR EDEMA (DME) AND AGE-RELATED MACULAR DEGENERATION (AMD), IN ITS EXUDATIVE FORM, AS PER PRIOR OPHTHALMOLOGIC EVALUATION AND FORMAL THERAPEUTIC INDICATION. THE PROCEDURES WERE CARRIED OUT IN AN APPROPRIATE ENVIRONMENT, IN STRICT COMPLIANCE WITH THE CURRENT INSTITUTIONAL PROTOCOL AND BIOSAFETY REGULATIONS, RIGOROUSLY INCLUDING THE FOLLOWING STEPS: INSTILLATION OF TOPICAL ANESTHETIC; INSTILLATION OF 5 PERCENT POVIDONE-IODINE (PVP-I) INTO THE CONJUNCTIVAL FORNIX, WITH A MINIMUM CONTACT TIME OF 5 MINUTES PRIOR TO THE PROCEDURE; ASEPSIS OF THE PERIOCULAR REGION; ADDITIONAL ANTISEPSIS USING AQUEOUS CHLORHEXIDINE SOLUTION; PLACEMENT OF A STERILE EYELID SPECULUM, AVOIDING CONTACT WITH EYELASHES AND EYELID MARGINS; REAPPLICATION OF PVP-I IMMEDIATELY PRIOR TO INJECTION; ADMINISTRATION OF INTRAVITREAL AFLIBERCEPT (EYLIA) INJECTION IN THE APPROPRIATE QUADRANT, AT A DISTANCE OF 3¿4 MM FROM THE CORNEOSCLERAL LIMBUS, ACCORDING TO LENS STATUS; INSTILLATION OF ANTIBIOTIC EYE DROPS AT THE END OF THE PROCEDURE. IT IS EMPHASIZED THAT THERE WERE NO CLINICAL SIGNS OF ACTIVE EXTERNAL OCULAR INFECTION (SUCH AS BLEPHARITIS OR CONJUNCTIVITIS) AT THE TIME OF THE PROCEDURE. IT IS FURTHER HIGHLIGHTED THAT FOR EACH TREATED EYE, COMPLETE ASEPTIC AND ANTISEPTIC STEPS WERE REPEATED, WITH FULL REPLACEMENT OF ALL STERILE MATERIALS, INCLUDING GLOVES, USING INDIVIDUALIZED STERILE KITS, IN STRICT COMPLIANCE WITH INSTITUTIONAL STANDARDS. MEDICATION USED: EYLIA (AFLIBERCEPT) BATCH: KT0V9JP MANUFACTURING DATE: 06/2025 EXPIRY DATE: 06/2027 TWO (2) VIALS WERE USED, WITH ALIQUOTING PERFORMED IMMEDIATELY PRIOR TO ADMINISTRATION, UNDER STRICTLY ASEPTIC CONDITIONS, WITHIN A STERILE FIELD, WITHOUT INTERMEDIATE STORAGE, IN ACCORDANCE WITH PRACTICES ADOPTED IN SPECIALIZED SERVICES. ALL PROCEDURES WERE COMPLETED WITHOUT IMMEDIATE TECHNICAL COMPLICATIONS. HOWEVER, AFTER THE PROCEDURES, 5 OUT OF 6 PATIENTS DEVELOPED CLINICAL FINDINGS CONSISTENT WITH INFECTIOUS ENDOPHTHALMITIS, PRESENTING SYMPTOMS SUCH AS: SEVERE OCULAR PAIN; OCULAR HYPEREMIA; SIGNIFICANT REDUCTION IN VISUAL ACUITY; HYPOPYON; VITREOUS OPACIFICATION; ULTRASONOGRAPHIC SIGNS CONSISTENT WITH INTRAOCULAR INFLAMMATORY/INFECTIOUS PROCESS. THE PATIENTS WERE PROMPTLY EVALUATED, TREATED ACCORDING TO THE INSTITUTIONAL PROTOCOL, UNDERWENT INTRAVITREAL ANTIBIOTIC INJECTIONS, AND REMAIN UNDER CONTINUOUS CLINICAL FOLLOW-UP. THEREFORE, I KINDLY REQUEST: FORMAL REGISTRATION OF THIS PHARMACOVIGILANCE NOTIFICATION; GUIDANCE ON THE INVESTIGATION PROCESS FOR A POTENTIAL QUALITY DEFECT; ASSESSMENT OF THE INVOLVED BATCH(ES); GUIDANCE REGARDING PRESERVATION/SHIPMENT OF REMAINING MATERIALS, IF NECESSARY; ISSUANCE OF AN ACKNOWLEDGMENT RECEIPT PROTOCOL FOR THIS COMMUNICATION. ADDITIONAL INFORMATION MAY BE PROVIDED UPON FORMAL REQUEST, IN COMPLIANCE WITH MEDICAL CONFIDENTIALITY AND APPLICABLE DATA PROTECTION LEGISLATION. ADDITIONAL INFORMATION: COULD YOU CONFIRM WHETHER THE COUNTRY OF EVENT OCCURRED IS BRAZIL? YES. COULD YOU CONFIRM WHETHER THE 5 CASES ARE ON THE SAME DATE? ON (B)(6) 2026, EIGHT (8) INTRAVITREAL INJECTIONS OF AN ANTI-VEGF AGENT (EYLIA ¿ AFLIBERCEPT) WERE ADMINISTERED TO SIX (6) PATIENTS, TOTALING EIGHT (8) TREATED EYES.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.