ISPAN 8065797005Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380657970056), received between May 21, 2021 and May 21, 2024 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER VITRECTOMY SURGERY SOME COMPLICATIONS WERE OBSERVED IN THE PATIENTS AFTER THEY ARE RECEIVING GAS IN THE EYE. ITS REPORTED THAT THERE WAS SPONTANEOUS DROPS IN INTRAOCULAR PRESSURE INTRAOPERATIVELY WHICH RESULTED IN TEMPORARY INTRAOPERATIVE DISCONNECTION OF THE CHOROID. THE CUSTOMER HAS ALSO PROVIDED THE INFORMATION WHICH STATES DUE TO THE DIAGNOSED THROMBOEMBOLIC CHANGES, VASCULAR TREATMENT WAS IMPLEMENTED DURING A FOLLOW-UP VISIT AFTER 2 WEEKS - IMPROVING RETINAL CIRCULATION. ADDITIONAL INFORMATION RECEIVED STATING THAT EIGHT PATIENTS WERE IMPACTED WITH THE REPORTED EVENT.

  Patient problems: Eye Injury; Intraocular Pressure Decreased

  MAUDE report 19360418 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INVESTIGATOR REPORTED IN A ABSTRACT AFTER USING SULFUR HEXAFLUORIDE (SF6) GAS TAMPONADE ON PATIENTS OPERATED FOR UNILATERAL LAMELLAR MACULAR HOLE (LMH). SOME PATIENTS EXPERIENCED POOR FINAL BEST-CORRECTED VISUAL ACUITY (BCVA).

  Patient problems: Visual Impairment

  MAUDE report 17787110 ↗
• MalfunctionSep 15, 2023Gas Output Problem; Gas Output Problem

  A CUSTOMER REPORTED THAT THE AN OPHTHALMIC GAS CYLINDER WAS LEFT UNPLUGGED AND SOMETIMES THERE WAS NOT ENOUGH GAS WHEN USING IT. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755208 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT POST VITREO RETINAL SURGERIES USING OPHTHALMIC GAS, PATIENTS EXPERIENCED INCREASE IN INTRAOCULAR PRESSURE AND TREATED WITH MEDICATION. THE SYMPTOMS WERE RESOLVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 17556993 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT THE PATIENT HAD AN INCREASE IN INTRAOCULAR PRESSURE POST INSTILLATION OF GAS INTO THE RIGHT EYE AFTER THE VITREORETINAL SURGERY. PATIENT RECEIVED TREATMENT (DIAMOX 500 MG PO BID AND COMBIGAN BID OD) FOR INCREASED INTRAOCULAR PRESSURE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 17555834 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA LITERATURE REPORT ABOUT TWO PATIENTS PRESENTED WITH DECREASED VISUAL ACUITY DUE TO EPIRETINAL MEMBRANE, BOTH PATIENTS UNDERWENT VITRECTOMY AND MEMBRANE PEELING. THE VITRECTOMY OPERATION WAS UNEVENTFUL AND WAS CONCLUDED WITH THE INSERTION OF OPHTHALMIC GAS TAMPONADE. BOTH EYES WERE PSEUDOPHAKIC AND HAD NO OTHER OCULAR OR SYSTEMIC PATHOLOGY. PATIENTS WERE CONTROLLED 24 HOURS FOLLOWING THE SURGERY AND BOTH PRESENTED WITH NORMAL ANTERIOR SEGMENT EXAMINATION AND NORMAL INTRAOCULAR PRESSURE. ON THE NEXT DAY OF SURGERY BOTH PATIENTS COMPLAINED OF CENTRAL SCOTOMA, AND BOTH HAD VERY DIFFICULT LIGHT PERCEPTION. FUNDUS EXAMINATION SHOWED DEVITALIZED MACULA STRUCTURES IN THE PRESENCE OF GAS BUBBLES OCCUPYING ALMOST 100% OF THE VITREOUS CAVITY. OCT (OPTICAL COHERENCE TOMOGRAPHY) EXAMINATION DONE A FEW DAYS AFTER SURGERY REVEALED NECROTIC RETINAL TISSUE. FOUR WEEKS LATER, BOTH EYES HAD LIGHT PERCEPTION VISION, AND DEVITALIZATION OF THE CENTRAL MACULA AND SPICULE-LIKE PIGMENT CHANGES IN THE MIDPERIPHERY OF THE RETINAL IN BOTH EYES. THIS REPORT IS FOR THE SECOND PATIENT (OD) INVOLVED IN THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Loss of Vision

  MAUDE report 17018161 ↗
• InjuryMay 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA LITERATURE REPORT ABOUT TWO PATIENTS PRESENTED WITH DECREASED VISUAL ACUITY DUE TO EPIRETINAL MEMBRANE, BOTH PATIENTS UNDERWENT VITRECTOMY AND MEMBRANE PEELING. THE VITRECTOMY OPERATION WAS UNEVENTFUL AND WAS CONCLUDED WITH THE INSERTION OF OPHTHALMIC GAS TAMPONADE. BOTH EYES WERE PSEUDOPHAKIC AND HAD NO OTHER OCULAR OR SYSTEMIC PATHOLOGY. PATIENTS WERE CONTROLLED 24 HOURS FOLLOWING THE SURGERY AND BOTH PRESENTED WITH NORMAL ANTERIOR SEGMENT EXAMINATION AND NORMAL INTRAOCULAR PRESSURE. ON THE NEXT DAY OF SURGERY BOTH PATIENTS COMPLAINED OF CENTRAL SCOTOMA, AND BOTH HAD VERY DIFFICULT LIGHT PERCEPTION. FUNDUS EXAMINATION SHOWED DEVITALIZED MACULA STRUCTURES IN THE PRESENCE OF GAS BUBBLES OCCUPYING ALMOST 100% OF THE VITREOUS CAVITY. OCT (OPTICAL COHERENCE TOMOGRAPHY) EXAMINATION DONE A FEW DAYS AFTER SURGERY REVEALED NECROTIC RETINAL TISSUE. FOUR WEEKS LATER, BOTH EYES HAD LIGHT PERCEPTION VISION, AND DEVITALIZATION OF THE CENTRAL MACULA AND SPICULE-LIKE PIGMENT CHANGES IN THE MIDPERIPHERY OF THE RETINAL IN BOTH EYES. THIS REPORT IS FOR THE FIRST PATIENT (OD) INVOLVED IN THIS EVENT.

  Patient problems: Inflammation; Loss of Vision; Visual Impairment

  MAUDE report 17017095 ↗
• MalfunctionFeb 15, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT DURING A SURGERY OPHTHALMIC GAS DOES NOT LAST AS LONG AS IT USED TO IN THE PATIENTS EYE. BOTH THE REGULATOR AND OPHTHALMIC GAS TANK WERE EXCHANGED AND STILL ISSUE HAD NOT RESOLVED. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16377744 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING A VITRECTOMY PROCEDURE TWO PATIENT'S EXPERIENCED RETINAL DAMAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED. THIS REPORT REPRESENTS PATIENT TWO OF TWO FROM THIS FACILITY.

  Patient problems: Retinal Injury

  MAUDE report 11863176 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING A VITRECTOMY PROCEDURE TWO PATIENT'S EXPERIENCED RETINAL DAMAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED. THIS REPORT REPRESENTS PATIENT ONE OF TWO FROM THIS FACILITY.

  Patient problems: Retinal Injury

  MAUDE report 11862984 ↗