ISPAN 8065797103Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00380657971039), received between Jan 3, 2022 and Dec 29, 2025 — classified as 35 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) - CLINICAL STUDY CENTER NUMBER 03, SUBJECT ID (B)(6). A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD HIGH INTRAOCULAR PRESSURE IN THE LEFT EYE FOLLOWING POSTERIOR VITRECTOMY WITH REPLACEMENT INJECTION+VITREOUS DRUG INJECTION+RETINAL LESION LASER COAGULATION+VITREOUS GAS-LIQUID EXCHANGE, RETINAL REPOSITIONING SURGERY DRUG THERAPY GIVEN. PATIENT RECOVERED. LOT NUMBER WAS UPDATED BY CLINICAL COLLEAGUE FROM 406501 TO 406405. THESE LOTS ARE FROM THE SAME MASTER LOT OF C3F8.

  Patient problems: Glaucoma

  MAUDE report 23910566 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  25L-11 - CLINICAL STUDY CENTER NUMBER 03, SUBJECT ID (B)(6). A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD SECONDARY GLAUCOMA IN THE LEFT EYE FOLLOWING POSTERIOR VITRECTOMY WITH REPLACEMENT INJECTION+VITREOUS DRUG INJECTION+RETINAL LESION LASER COAGULATION+VITREOUS GAS-LIQUID EXCHANGE, RETINAL REPOSITIONING SURGERY. DRUG THERAPY GIVEN. PATIENT RECOVERED.

  Patient problems: Glaucoma

  MAUDE report 23879031 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) - CLINICAL STUDY CENTER NUMBER 03, SUBJECT ID (B)(6). A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD HIGH INTRAOCULAR PRESSURE IN THE LEFT EYE FOLLOWING POSTERIOR VITRECTOMY WITH REPLACEMENT INJECTION+VITREOUS DRUG INJECTION+RETINAL LESION LASER COAGULATION+VITREOUS GAS-LIQUID EXCHANGE, RETINAL REPOSITIONING SURGERY. DRUG THERAPY GIVEN. PATIENT RECOVERED. LOT NUMBER WAS UPDATED BY CLINICAL COLLEAGUE FROM 406501 TO 406405. THESE LOTS ARE FROM THE SAME MASTER LOT OF C3F8.

  Patient problems: Glaucoma

  MAUDE report 23832205 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  25K-15 - CLINICAL STUDY CENTER NUMBER: (B)(6), SUBJECT ID: (B)(6). NOTE: SAME PATIENT AND SAME EYE AS 25I-12, (B)(4) (MDR 2518435-2025-00043). SURGERY DATE FOR 25I-12 IS UNKNOWN. DIFFERENT START DATE OF ISSUE REPORTED IN THIS SUBMISSION. A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD INCREASE IN INTRAOCULAR PRESSURE IN THE LEFT EYE FOLLOWING PHACOEMULSIFICATION+IOL IMPLANTATION+POSTERIOR CAPSULOTOMY + VITRECTOMY WITH MEMBRANE PEELING, HEAVY WATER ENDOLASER+PHOTOCOAGULATION, GAS-FLUID EXCHANGE AND C3F8 GAS INJECTION. PHARMOCOTHERAPY GIVEN. PATIENT RECOVERED.

  Patient problems: Glaucoma

  MAUDE report 23575197 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL TRIAL STUDY, CENTER NUMBER 06, SUBJECT ID (B)(6). A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD ELEVATED INTRAOCULAR PRESSURE IN THE LEFT EYE FOLLOWING PHACO+IOL IMPLANTATION+POSTERIOR CAPSULE INCISION + VITRECTOMY HEAVY WATER PHOTOPOLYMERAZATION GAS- LIQUID EXCHANGE INJECTION (C3F8) MEDICATION INJECTION SURGERY. DRUG THERAPY WAS GIVEN, PATIENT RECOVERED.

  Patient problems: Glaucoma

  MAUDE report 23544737 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL TRIAL STUDY, CENTER 03, SUBJECT (B)(6). A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD POSTOPERATIVE SECONDARY GLAUCOMA IN THE RIGHT EYE FOLLOWING PARS PLANA VITRECTOMY+INTRAVITREAL INJECTION + RETINAL LASER PHOTOCOAGULATION+COMPLEX RETINAL DETACHMENT REPAIR WITH INTERNAL TAMPONADE. PHARMACOTHERAPY WAS GIVEN, PATIENT RECOVERED.

  Patient problems: Glaucoma

  MAUDE report 23533204 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL TRIAL STUDY, (B)(6), SUBJECT (B)(6). A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD POSTOPERATIVE SECONDARY HIGH INTRAOCULAR PRESSURE IN THE RIGHT EYE FOLLOWING VITRECTOMY+ VITREOUS PUNCTURE INJECTION+RETINAL LASER PHOTOCOAGULATION+COMPLEX RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY. DRUG THERAPY WAS GIVEN, PATIENT RECOVERED.

  Patient problems: Glaucoma

  MAUDE report 23522432 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL TRIAL STUDY, (B)(6), SUBJECT (B)(6). A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MODERATE POSTOPERATIVE INCREASED INTRAOCULAR PRESSURE IN THE LEFT EYE FOLLOWING VITRECTOMY WITH MEMBRANE PEELING, ENDOLASER PHOTOCOAGULATION, RETINAL REPAIR, GAS FLUID EXCHANGE, USE OF HEAVY WATER, C3F8 GAS FILL, AND POSTERIOR CAPSULOTOMY. PHARMOCOTHERAPY WAS GIVEN, PATIENT RECOVERED.

  Patient problems: Glaucoma

  MAUDE report 23522431 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6)_CLINICAL TRIAL STUDY. A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD POSTOPERATIVE HIGH INTRAOCULAR PRESSURE IN THE RIGHT EYE FOLLOWING VITRECTOMY+VITREOUS PUNCTURE INJECTION + INTERNAL OPHTHALMOPATHY CONDENSATION + COMPLEX RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY. DRUG THERAPY GIVEN, PATIENT RECOVERED. UPDATE: LOT UPDATED BY ALCON ON DECEMBER 24, 2025, FROM 406501 TO 406405. THESE LOTS ARE FROM THE SAME MASTER LOT OF C3F8.

  Patient problems: Glaucoma

  MAUDE report 23451304 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL TRIAL STUDY. A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD OCULAR FULLNESS OR PRESSURE SENSATION IN THE LEFT EYE FOLLOWING PHACOEMULSIFICATION AND ASPIRATION OF CATARACT + CATARACT EXTRACTION WITH PRIMARY INTRAOCULAR LENS IMPLANTATION + PARS PLANA VITRECTOMY WITH TAMPONADE+INTRAVITREAL DRUG INJECTION+EPIRETINAL MEMBRANE PEELING+LASER PHOTOCOAGULATION FOR RETINAL DETACHMENT+VITREOUS FLUID AIR EXCHANGE AND RETINAL REATTACHMENT SURGERY. NO MEASURES WERE TAKEN, PATIENT RECOVERED. UPDATE DECEMBER 29, 2025: LOT NUMBER UPDATED TO 406405, SAME MASTER LOT AS 406501.

  Patient problems: Glaucoma

  MAUDE report 23451210 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6)_CLINICAL STUDY CENTER NUMBER (B)(6), SUBJECT ID (B)(6) PFP LOT 406501 PATIENTS EXPERIENCED MODERATE ELEVATED INTRAOCULAR PRESSURE IN THE LEFT EYE FOLLOWING PHACO + IOL IMPLANTATION +VITRECTOMY MEMBRANE STRIPPING HEAVY WATER PHOTOPOLYMERIZATION GAS-LIQUID EXCHANGE GAS INJECTION (C3F8) SURGERY. MEDICAL TREATMENT GIVEN, CURRENT CONDITION IS "NO CHANGE."

  Patient problems: Glaucoma

  MAUDE report 23450836 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4)_CLINICAL TRIAL STUDY: A HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING A PATIENT EXPERIENCED MILD OCULAR HYPERTENSION FOLLOWING LEFT EYE PHACOEMULSIFICATION + IOL IMPLANTATION + VITRECTOMY WITH MEMBRANE PEELING PHOTOCOAGULATION AND C3F8 GAS INJECTION SURGERY. CURRENT CONDITION OF PATIENT IS RESOLVED. NOTE: THIS IS THE SAME SURGERY DATE, SAME PATIENT, SAME EYE AS COMPLAINT (B)(4), MDR 2518435-2025-00032, WITH A DIFFERENT ONSET DATE OF ADVERSE EVENT. LOT C3F8 406405 WAS REPORTED FOR THIS COMPLAINT, WHERE THERE WAS A LOT NUMBER CORRECTION TO LOT 406501 FOR COMPLAINT (B)(4). LOTS 406405 AND 406501 ARE FROM THE SAME C3F8 MASTER LOT.

  Patient problems: Glaucoma

  MAUDE report 23309117 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE COMPLAINT (B)(4) CASE FROM CLINICAL STUDY (B)(6), SUBJECT ID (B)(6), PATIENT(B)(6). A HEALTH CARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD INCREASE IN INTRAOCULAR PRESSURE IN THE LEFT EYE AFTER VITRECTOMY, MEMBRANE STRIPPING, PHOTOCOAGULATION, HEAVY WATER, MESH RESTORATION, GAS-FLUID EXCHANGE GAS INJECTION (C3F8), PHACO+IOL SURGERY. SURGERY DATE (B)(6) 2025. THE PATIENT WAS GIVEN MEDICAL TREATMENT. OUTCOME IS RESOLVED. PFP LOT NUMBER 406501 REPORTED.

  Patient problems: Glaucoma

  MAUDE report 23285685 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4)_CLINICAL TRIAL STUDY, CENTER NUMBER 6. SUBJECT ID (B)(6). PATIENT EXPERIENCED MILD ELEVATED INTRAOCULAR PRESSURE (LEFT EYE) FOLLOWING LEFT EYE VITRECTOMY+MEDICATION INJECTION (TA)+MESH RESTORATION+PHOTOCOAGULATION+HEAVY WATER+GAS-LIQUID EXCHANGE+GAS INJECTION (C3F8) SURGERY. MEDICAL TREATMENT GIVEN, CURRENT CONDITION IS "NO CHANGE".

  Patient problems: Glaucoma

  MAUDE report 23278568 ↗
• InjurySep 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL TRIAL STUDY, (B)(6) CENTER NUMBER 6. SUBJECT ID (B)(6) PATIENT EXPERIENCED MILD ELEVATED INTRAOCULAR PRESSURE (LEFT EYE) FOLLOWING VITRECTOMY SURGERY WITH ISPAN C3F8 GAS. MEDICAL TREATMENT GIVEN, CURRENT CONDITION IS "IMPROVING". UPDATED 12/1/2025: MEDICATION TREATMENT WAS GIVEN AND CONDITION IS RESOLVED. SURGERY DATE UPDATED TO (B)(6) /2025, EVENT DATE 09/11/2025.

  Patient problems: Glaucoma

  MAUDE report 23109186 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4)_CLINICAL TRIAL STUDY, SUBJECT ID: (B)(6). MILD POSTOPERATIVE IOP (LEFT EYE) FOLLOWING VITRECTOMY + VITREOUS INJECTION + RETINAL LASER PHOTOCOAGULATION + RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY. DRUG THERAPY GIVEN, OUTCOME IS "RECOVERY."

  Patient problems: Glaucoma

  MAUDE report 23040271 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). CLINICAL TRIAL STUDY, CENTER NUMBER 6. SUBJECT ID: (B)(6). PATIENT EXPERIENCED MILD ELEVATED INTRAOCULAR PRESSURE (LEFT EYE) FOLLOWING VITRECTOMY, MEMBRANE STRIPPING, PHOTOPOLYMERIZATION, HEAVY WATER GAS-LIQUID EXCHANGE, DRUG INJECTION (TA), GAS INJECTION (C3F8) + PHACO +IOL IMPLANTATION + POSTERIOR CAPSULE INCISION SURGERY. DRUG THERAPY GIVEN, OUTCOME IS "RECOVERY."

  Patient problems: Glaucoma

  MAUDE report 23040235 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  25I-07_CLINICAL TRIAL STUDY, SUBJECT ID (B)(4). MODERATE INCREASE IN IOP (RIGHT EYE) FOLLOWING VITRECTOMY HEAVY WATER PHOTOPOLYMERIZATION GAS-LIQUID EXCHANGE GAS INJECTION (C3F8) SURGERY. DRUG THERAPY GIVEN, OUTCOME IS "NO CHANGE."

  Patient problems: Glaucoma

  MAUDE report 23040136 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4)_CLINICAL TRIAL STUDY, SUBJECT ID (B)(6), REPORT CENTER 03 MILD INCREASE IN IOP (RIGHT EYE) FOLLOWING VITRECTOMY + VITREOUS PUNCTURE INJECTION + PRE MEMBRANE PEELING FOR COMPLEX RETINAL DETACHMENT REPAIR + RETINAL LASER PHOTOCOAGULATION + COMPLEX RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY. NO MEASURES TAKEN, OUTCOME IS "RECOVERY."

  Patient problems: Glaucoma

  MAUDE report 23004424 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  25G-24_CLINICAL TRIAL STUDY. MILD INCREASE IN IOP (LEFT EYE) FOLLOWING PHACOEMULSIFICATION +IOL IMPLANTATION+POSTERIOR CAPSULOTOMY +VITRECTOMY, WITH MEMBRANE PEELING, ENDOLASER, FLUID-AIR EXCHANGE WITH C3F8 GAS INJECTION. THIS IS THE SECOND EVENT ASSOCIATED WITH THE SAME SURGERY. FIRST REPORT WAS SUBMITTED AS 2518435-2025-00035. ONSET DATE OF FIRST EVENT WAS 04/29/2025, THIS SECOND EVENT ONSITE DATE IS 06/03/2025. BOTH EVENTS ARE REPORTED AS "RECOVERED".

  Patient problems: Glaucoma

  MAUDE report 22579345 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6)_CLINICAL TRIAL STUDY A HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING A VITRECTOMY PROCEDURE IN THE LEFT EYE FOR RETINAL REATTACHMENT, PHOTOCOAGULATION, AND GAS EXCHANGE WITH AN OPHTHALMIC GAS, THE PATIENT EXPERIENCED INCREASED INTRAOCULAR PRESSURE TWENTY-TWO DAYS AFTER THE PROCEDURE, POSSIBLY CAUSED BY GAS EXPANSION. THE PATIENT WAS TREATED WITH MEDICATION, BUT THE ISSUE PERSISTED FOR TWENTY-ONE DAYS. CURRENT CONDITION OF PATIENT IS RESOLVED. ORIGINALLY, LOT 406405 WAS REPORTED, THIS WAS UPDATED TO LOT 406501 ON 15JULY2025. NOTE: LOTS 406405 AND 406501 ARE FROM THE SAME C3F8 MASTER LOT.

  Patient problems: Glaucoma

  MAUDE report 22440751 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  25G-11_CLINICAL TRIAL STUDY MILD INCREASE IN IOP (LEFT EYE) FOLLOWING PHACO+IOL +POSTERIOR CAPSULE INCISION+REMOVAL OF PRESSURE BLOCK +VITRECTOMY, PHOTOCOAGULATION, GAS INJECTION (C3F8) SURGERY.

  Patient problems: Glaucoma

  MAUDE report 22435735 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6)_CLINICAL TRIAL STUDY MILD INCREASE IN IOP (LEFT EYE) FOLLOWING PHACOEMULSIFICATION +IOL IMPLANTATION+POSTERIOR CAPSULOTOMY +VITRECTOMY, WITH MEMBRANE PEELING, ENDOLASER, FLUID-AIR EXCHANGE WITH C3F8 GAS INJECTION.

  Patient problems: Glaucoma

  MAUDE report 22435514 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE COMPLAINT (B)(4). CASE FROM CLINICAL STUDY (B)(6), SUBJECT ID (B)(6), PATIENT (B)(6). A HEALTH CARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD ELEVATED INTRAOCULAR PRESSURE IN THE LEFT EYE AFTER PARS PLANA VITRECTOMY WITH MEMBRANE PEELING, HEAVY WATER, PHOTOCOAGULATION, FLUID GAS EXCHANGE, INTRAOCULAR DRUG INJECTION AND GAS INJECTION (C3F8). THE PATIENT WAS GIVEN MEDICAL TREATMENT. CURRENT OUTCOME IS "NO CHANGE". PFP LOT NUMBER 406405 WAS INITIALLY PROVIDED, BUT THE FOLLOW UP DETAILS IN THE REPORT STATE THAT THE LOT WAS UPDATED TO 406501 ON 26 MAY 2025.

  Patient problems: Glaucoma

  MAUDE report 22292659 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE COMPLAINT (B)(4). CASE FROM CLINICAL STUDY (B)(6), SUBJECT ID (B)(6), PATIENT (B)(6). A HEALTH CARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD ELEVATED INTRAOCULAR PRESSURE IN THE LEFT EYE AFTER PHACOEMULSIFICATION WITH IOL IMPLANTATION, PARS PLANA VITRECTOMY WITH MEMBRANE PEELING, PHOTOCOAGULATION, GAS-FLUID EXCHANGE AND GAS INJECTION (C3F8). THE PATIENT WAS GIVEN MEDICAL TREATMENT. OUTCOME IS RECOVERED. PFP LOT NUMBER 406405 WAS INITIALLY PROVIDED, BUT THE FOLLOW UP DETAILS IN THE REPORT STATE THAT THE LOT WAS UPDATED TO 406501 ON (B)(6) 2025.

  Patient problems: Glaucoma

  MAUDE report 22289595 ↗