ISPAN 8065797105Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00380657971053), received between May 6, 2021 and Jan 9, 2024 — classified as 13 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT DURING PARS PLANA VITRECTOMIES WITH RETINAL DETACHMENT SURGERY, AN OPHTHALMIC GAS WAS BEING DISPENSED TO PATIENTS AND GAS BUBBLES IN THE EYE WERE BEING ABSORBED AT A FASTER RATE THAN NORMAL IN MULTIPLE POST OPERATIVE PATIENTS. ISSUE WAS NOT RESOLVED EVEN AFTER CHANGING GAS BOTTLES AND SYRINGES. AN OPHTHALMIC SYSTEM DID NOT ACCURATELY DISPENSE THE VOLUME OF UNDILUTED GAS CLAIMED TO HAVE BEEN DISPENSED IN THE PROMPT DUE TO AN ISSUE WITH THE PURGE STEPS OF THE GAS DISPENSING PROCESS. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 18474231 ↗
• MalfunctionApr 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT DURING PNEUMATIC RETINOPEXY SURGERY PERFLUOROPROPANE GAS BUBBLE LASTED FOR SHORTER DURATION AND GAS REGULATOR DID NOT ENOUGH PRESSURE TO FORCE SYRINGE .THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16730652 ↗
• MalfunctionMar 1, 2023Gas Output Problem; Gas Output Problem

  A PHYSICIAN REPORTED THAT OPHTHALMIC OPERATING CONSOLE EXHIBIT THE PERFLUOROPROPANE GAS BUBBLE IN PATIENT EYE WAS REDUCED TO UNUSUAL SIZE AND INADEQUATE PERFLUOROPROPANE GAS WAS FILLED IN THE PATIENT EYE AND IT WAS NOTICED ON POST OPERATIVE DAY EIGHT. THERE WAS NO DETAILS OF THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459445 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS EXPERIENCED ELEVATED INTRAOCULAR PRESSURE WITH MILD SEVERITY AND WAS TREATED BY MEDICATION. THE SYMPTOMS WERE RESOLVED. PROCEDURE DETAILS WERE NOT REPORTED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 15985729 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE REPORTED THAT INTRAOCULAR PRESSURE INCREASED IN BOTH EYES (26MMHG) WITH MODERATE SEVERITY WHICH WAS TREATED BY MEDICINE. THE CURRENT CONDITION OF THE PATIENT WAS NOT REPORTED. THE DETAILS ABOUT PROCEDURE WAS NOT REPORTED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 15985029 ↗
• MalfunctionNov 18, 2022Short Fill; Short Fill

  A NURSE REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCED SHORTER BUBBLE DURATION WHEN AN OPHTHALMIC GAS WERE USED. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824181 ↗
• MalfunctionNov 18, 2022Gas Output Problem; Appropriate Device Problem Term/Code Not Available; Gas Output Problem; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED THAT PERFLUOROPROPANE GAS BUBBLE IN EYE REDUCED IN SIZE PREMATURELY IN THE PATIENT EYE. PROCEDURE WAS COMPLETED AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THE EVENT OCCURRED DURING SURGERY BUT NOT NOTED UNTIL POST OPERATIVE (POST-OP). THE GAS FILL WAS NOTED TO BE LOW AT POST-OP AND PERFLUOROPROPANE WAS NOT DISPENSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824179 ↗
• MalfunctionNov 18, 2022Gas Output Problem; Gas/Air Leak; Gas Output Problem; Gas/Air Leak

  A PHYSICIAN REPORTED THAT AFTER A VITRECTOMY PROCEDURE FOR RECURRENT RETINAL DETACHMENT, ON POST OPERATIVE DAY 10 THE SURGEON FOUND ONLY 30% OF GAS WAS FILLED IN PATIENT¿S EYE, THEY NOTICED THE SYSTEM WAS IMPROPERLY DISPENSED GAS AND WAS LEAKING SOMEWHERE THAT CAUSED ROOM AIR TO BE DRAWN UP. IT WAS INFORMED THAT AN OPHTHALMIC GAS AND AN OPHTHALMIC OPERATING CONSOLE WERE USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824177 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT DEVELOPED WITH MODERATE HIGH INTRAOCULAR PRESSURE WHICH REQUIRED MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 15815160 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING A SURGERY HIGH INTRAOCULAR PRESSURE WAS OBSERVED WITH AN OPHTHALMIC GAS. THE EVENT AS RESOLVED AFTER MEDICAL TREATMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 15814954 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING A SURGERY HIGH INTRAOCULAR PRESSURE WAS OBSERVED WITH AN OPHTHALMIC GAS. THE EVENT AS RESOLVED AFTER MEDICAL TREATMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 15814950 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT AFTER SURGERY BY USING AN OPHTHALMIC GAS, A PATIENT EXPERIENCED MODERATE FEVER. THE PATIENT WAS TREATED BY USING DRUG THERAPY. ALL THE SYMPTOMS HAVE RESOLVED.

  Patient problems: Fever

  MAUDE report 15814206 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT A PATIENT WAS EXPERIENCED HIGH INTRA OCULAR PRESSURE (IOP) AND WAS GIVEN WITH MEDICAL TREATMENT. THE PROCEDURE DETAILS WERE NOT PROVIDED. THE SYMPTOMS WERE RESOLVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 15813665 ↗
• MalfunctionAug 18, 2022Short Fill; Short Fill

  A NURSE REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCED SHORTER BUBBLE DURATION WHEN AN OPHTHALMIC GAS WERE USED. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248434 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT DEVELOPED WITH MODERATE HIGH INTRAOCULAR PRESSURE WHICH REQUIRED MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 15157240 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT A PATIENT WAS EXPERIENCED HIGH INTRA OCULAR PRESSURE (IOP) AND WAS GIVEN WITH MEDICAL TREATMENT. THE PROCEDURE DETAILS WERE NOT PROVIDED. THE SYMPTOMS WERE RESOLVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 15146708 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT AFTER SURGERY BY USING AN OPHTHALMIC GAS, A PATIENT EXPERIENCED MODERATE FEVER. THE PATIENT WAS TREATED BY USING DRUG THERAPY. ALL THE SYMPTOMS HAVE RESOLVED.

  Patient problems: Fever

  MAUDE report 14515717 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING A SURGERY HIGH INTRAOCULAR PRESSURE WAS OBSERVED WITH AN OPHTHALMIC GAS. THE EVENT AS RESOLVED AFTER MEDICAL TREATMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 14491027 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING A SURGERY HIGH INTRAOCULAR PRESSURE WAS OBSERVED WITH AN OPHTHALMIC GAS. THE EVENT AS RESOLVED AFTER MEDICAL TREATMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 14475348 ↗
• MalfunctionMay 19, 2022Gas Output Problem; Gas/Air Leak; Gas Output Problem; Gas/Air Leak

  THIS REPORT REPRESENTS GAS INVOLVED IN THIS EVENT. A PHYSICIAN REPORTED THAT AFTER A VITRECTOMY PROCEDURE FOR RECURRENT RETINAL DETACHMENT, ON POST OPERATIVE DAY 10 THE SURGEON FOUND ONLY 30% OF GAS WAS FILLED IN PATIENT¿S EYE, THEY NOTICED THE SYSTEM WAS IMPROPERLY DISPENSED GAS AND WAS LEAKING SOMEWHERE THAT CAUSED ROOM AIR TO BE DRAWN UP. IT WAS INFORMED THAT AN OPHTHALMIC GAS AND AN OPHTHALMIC OPERATING CONSOLE WERE USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14445276 ↗
• MalfunctionMay 19, 2022Gas Output Problem; Appropriate Device Problem Term/Code Not Available; Gas Output Problem; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED THAT PERFLUOROPROPANE GAS BUBBLE IN EYE REDUCED IN SIZE PREMATURELY IN THE PATIENT EYE. PROCEDURE WAS COMPLETED AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THE EVENT OCCURRED DURING SURGERY BUT NOT NOTED UNTIL POST OPERATIVE (POST-OP). THE GAS FILL WAS NOTED TO BE LOW AT POST-OP AND PERFLUOROPROPANE WAS NOT DISPENSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14445076 ↗
• MalfunctionJan 5, 2022Gas Output Problem; Gas Output Problem

  A PHYSICIAN REPORTED THAT DURING A SURGERY GAS WAS NOT FLOWING FROM THE GAS CYLINDER AND THE PRESSURE GAUGE INDICATED ZERO PRESSURE. SURGERY WAS COMPLETED USING A BACKUP GAS CYLINDER. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13168672 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AUTHOR IN A LITERATURE ARTICLE REPORTED THAT 41 PATIENTS WHO HAD EXPERIENCED EYE PERFORATIONS, MISSILE INJURIES TO THE EYE AND FOREIGN BODY IN THE EYE RECEIVED EITHER OPHTHALMIC SILICONE OIL OR OPHTHALMIC PERFLUOROCARBON GAS DURING SEPARATE VITRECTOMY SURGERIES. AT SIX MONTHS POST-OPERATIVE FOLLOW UP, THESE PATIENTS SUBSEQUENTLY EXPERIENCED ANY OF THE FOLLOWING: EYE ATROPHY, ENUCLEATION, HYPOTONY, ENDOPHTHALMITIS AND DECREASED VISUAL ACUITY. ADDITIONAL INFORMATION WAS REQUESTED. FURTHER PATIENT IDENTIFICATION IS NOT AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Endophthalmitis; Visual Impairment

  MAUDE report 11784328 ↗