ISPAN 8065797102Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00380657971022), received between Aug 4, 2021 and Apr 21, 2026 — classified as 79 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Short Fill” (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 84 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  COMPLIANT ID: (B)(4). SUBJECT ID: (B)(6). A CLINICAL STUDY REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE DRY EYE SYNDROME (RIGHT EYE). SURGICAL DATE: (B)(6) 2022. EVENT START: (B)(6) 2022. EVENT END: (B)(6) 2022. MEASURES TAKEN: MEDICATION TREATMENT. AE OUTCOME: RESOLVED. SURGICAL NAME: VITRECTOMY+VITREOUS PUNCTURE INJECTION+COMPLEX RETINAL DETACHMENT REPAIR WITH ANTERIOR MEMBRANE PEELING+RETINAL LASER PHOTOCOAGULATION+RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY (LEFT EYE).

  Patient problems: Dry Eye(s)

  MAUDE report 24940504 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  COMPLIANT ID: (B)(4). SUBJECT ID: (B)(6). A CLINICAL STUDY REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE LOCALIZED SHALLOW RETINAL DETACHMENT (RIGHT EYE). SURGICAL DATE: (B)(6) 2022. EVENT START: AUGUST 17, 2022. EVENT END: SEPTEMBER 07, 2022. MEASURES TAKEN: NON MEDICATION TREATMENT. AE OUTCOME: RESOLVED. SURGICAL PROCEDURES: VITRECTOMY+VITREOUS PUNCTURE INJECTION+RETINAL LASER PHOTOCOAGULATION+COMPLEX. ETINAL DETACHMENT ANTERIOR MEMBRANE PEELING SURGERY+COMPLEX RETINAL DETACHMENT REPAIR. URGERY+RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY (RIGHT EYE).

  Patient problems: Retinal Detachment

  MAUDE report 24940480 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  COMPLIANT ID: (B)(4). SUBJECT ID: (B)(6). A CLINICAL STUDY REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE POSTOPERATIVE HIGH INTRAOCULAR PRESSURE (24MMHG IN THE RIGHT EYE). SURGICAL DATE: (B)(6) 2022. EVENT START: (B)(6) 2022. EVENT END: (B)(6) 2022. MEASURES TAKEN: MEDICATION TREATMENT. AE OUTCOME: RESOLVED. SURGICAL PROCEDURES: VITRECTOMY, VITREOUS PUNCTURE INJECTION, RETINAL LASER PHOTOCOAGULATION, COMPLEX RETINAL DETACHMENT ANTERIOR MEMBRANE PEELING SURGERY, COMPLEX RETINAL DETACHMENT REPAIR URGERY, RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY (RIGHT EYE).

  Patient problems: Intraocular Pressure Increased

  MAUDE report 24940472 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  COMPLIANT ID: (B)(4). A CLINICAL STUDY (B)(6) REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE POSTERIOR CAPSULAR OPACIFICATION (RIGHT EYE). SURGICAL DATE: (B)(6) 2022. EVENT START: JULY 26, 2022. EVENT END: JULY 26, 2022. MEASURES TAKEN: NON-MEDICATION TREATMENT. AE OUTCOME: RESOLVED. PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION + PARS PLANA VITRECTOMY + INTRAVITREAL INJECTION + RETINAL LASER PHOTOCOAGULATION + INTERNAL TAMPONADE FOR RETINAL DETACHMENT REPAIR (RIGHT EYE).

  Patient problems: Visual Impairment

  MAUDE report 24873503 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  COMPLIANT ID: (B)(6). A CLINICAL STUDY ((B)(4)) REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE ELEVATED INTRAOCULAR PRESSURE (LEFT EYE, T+3). SURGICAL DATE: (B)(6) 2022. EVENT START: (B)(6) 2022. EVENT END: (B)(6) 2022. MEASURES TAKEN: PHARMACOLOGICAL TREATMENT. AE OUTCOME: RECOVERED. PHACOEMULSIFICATION CATARACT EXTRACTION + VITRECTOMY + INTRAVITREAL INJECTION + EPIRETINAL MEMBRANE. PEELING PRIOR TO COMPLEX RETINAL DETACHMENT REPAIR + MACULAR HOLE CLOSURE + RETINAL LASER. PHOTOCOAGULATION + INTERNAL TAMPONADE FOR COMPLEX RETINAL DETACHMENT (LEFT EYE).

  Patient problems: Intraocular Pressure Increased

  MAUDE report 24873486 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  COMPLIANT ID: (B)(6). A CLINICAL STUDY REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE ELEVATED INTRAOCULAR PRESSURE (42MMHG IN THE RIGHT EYE). SURGICAL DATE: (B)(6) 2022. EVENT START: (B)(6) 2022. EVENT END: (B)(6) 2022. MEASURES TAKEN: DRUG THERAPY AND NON-DRUG THERAPY. AE OUTCOME: RECOVERY. SURGICAL PROCEDURES: VITRECTOMY + VITREOUS PUNCTURE INJECTION + RETINAL LASER PHOTOCOAGULATION + COMPLEX. RETINAL DETACHMENT REPAIR WITH ANTERIOR MEMBRANE PEELING + COMPLEX RETINAL DETACHMENT REPAIR + INTERNAL PRESSURE REPAIR FOR RETINAL DETACHMENT (RIGHT EYE).

  Patient problems: Intraocular Pressure Increased

  MAUDE report 24873438 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  COMPLIANT ID: (B)(4). A CLINICAL STUDY REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE ELEVATED INTRAOCULAR PRESSURE (RIGHT EYE: 40 MMHG). SURGICAL DATE: (B)(6) 2022. EVENT START: (B)(6) 2022. EVENT END: (B)(6) 2022. MEASURES TAKEN: MEDICATION TREATMENT. AE OUTCOME: RESOLVED. SURGICAL PROCEDURES: PARS PLANA VITRECTOMY + INTRAVITREAL INJECTION + MEMBRANE PEELING FOR COMPLEX RETINAL. DETACHMENT REPAIR + RETINAL LASER PHOTOCOAGULATION + INTRAOCULAR GAS TAMPONADE (RIGHT EYE).

  Patient problems: Intraocular Pressure Increased

  MAUDE report 24873428 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  COMPLIANT ID: (B)(6). A CLINICAL STUDY REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE CONCURRENT CATARACT (RIGHT EYE). SURGICAL DATE: (B)(6) 2022. EVENT START: (B)(6) 2022. VITRECTOMY + VITREOUS PUNCTURE INJECTION + RETINAL LASER PHOTOCOAGULATION + COMPLEX RETINAL DETACHMENT REPAIR WITH ANTERIOR MEMBRANE PEELING + COMPLEX RETINAL DETACHMENT REPAIR +. INTERNAL PRESSURE REPAIR FOR RETINAL DETACHMENT (RIGHT EYE).

  Patient problems: Cataract

  MAUDE report 24873419 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  COMPLIANT ID: (B)(6). A CLINICAL STUDY REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE ELEVATED INTRAOCULAR PRESSURE (26MMHG IN THE RIGHT EYE). SURGICAL DATE: (B)(6) 2022. EVENT START: (B)(6) 2022. EVENT END: (B)(6) 2022. MEASURES TAKEN: DRUG THERAPY. AE OUTCOME: RECOVERY. SURGICAL PROCEDURES: VITRECTOMY +VITREOUS PUNCTURE INJECTION SURGERY + COMPLEX RETINAL DETACHMENT REPAIR. ANTERIOR MEMBRANE PEELING SURGERY + RETINAL LASER PHOTOCOAGULATION SURGERY + RETINAL DETACHMENT. INTERNAL PRESSURE REPAIR SURGERY (LEFT EYE).

  Patient problems: Intraocular Pressure Increased

  MAUDE report 24873399 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  COMPLIANT ID: (B)(6) A CLINICAL STUDY REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE GLAUCOMA IN THE RIGHT EYE. SURGICAL DATE: (B)(6) 2022. EVENT START: (B)(6) 2022. EVENT END: (B)(6) 2026. MEASURES TAKEN: MEDICATION TREATMENT AND NON-MEDICATION TREATMENT. AE OUTCOME: RESOLVED. SURGICAL PROCEDURES: PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION + PARS PLANA VITRECTOMY + INTRAVITREAL INJECTION + RETINAL LASER PHOTOCOAGULATION + INTERNAL TAMPONADE FOR RETINAL DETACHMENT REPAIR; (RIGHT EYE).

  Patient problems: Glaucoma

  MAUDE report 24873387 ↗
• 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 (B)(4). SUBJECT ID (B)(6). PATIENT EXPERIENCED MILD SUBCONJUNCTIVAL HEMORRHAGE IN THE LEFT EYE FOLLOWING PARS PLANA VITRECTOMY+RETINAL LESION LASER PHOTOCOAGULATION + INTRAVITREAL GAS INJECTION, RETINAL REPOSITIONING SURGERY+VITREOUS GAS-LIQUID EXCHANGE. SURGERY DATE (B)(6) 2025 START OF INCIDENT (B)(6) 2025. DRUG THERAPY GIVEN. OUTCOME IS RECOVERED.

  Patient problems: Conjunctival Hemorrhage

  MAUDE report 23278474 ↗
• 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 (B)(4). SUBJECT ID (B)(6). PATIENT EXPERIENCED MILD ELEVATED INTRAOCULAR PRESSURE FOLLOWING LEFT EYE POSTERIOR APPROACH VITRECTOMY+RETINAL LESION CRYOSURGERY+INTRAVITREAL GAS INJECTION, RETINAL REATTACHMENT SURGERY+VITREOUS GAS-LIQUID EXCHANGE+CATARACT PHACOEMULSIFICATION AND ASPIRATION SURGERY. SURGERY DATE (B)(6) 2025 START OF INCIDENT (B)(6) 2025. DRUG THERAPY GIVEN. OUTCOME IS RESOLVED.

  Patient problems: Glaucoma

  MAUDE report 23278422 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE HIGH INTRAOCULAR PRESSURE RESOLVED IN TWO MONTHS.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 21400483 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY FOR RIGHT EYE, THE PATIENT EXPERIENCED SECONDARY HIGH INTRAOCULAR PRESSURE (IOP). THE SEVERITY OF THE EVENT WAS MILD. THE PATIENT UNDERWENT AN ADDITIONAL MEDICAL TREATMENT AND WAS RESOLVED. THE HIGH IOP WAS RESOLVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 21395991 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN REPORTED THAT DURING VITRECTOMY, VITREOUS PUNCTURE INJECTION, PRE-MEMBRANE PEELING FOR COMPLEX RETINAL DETACHMENT REPAIR, RETINAL LASER PHOTOCOAGULATION, COMPLEX RETINAL DETACHMENT REPAIR, COMPLEX RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY FOR LEFT EYE, THE PATIENT EXPERIENCED MILD HIGH INTRAOCULAR PRESSURE (IOP), SECONDARY GLAUCOMA AND UNDERWENT AN ADDITIONAL MEDICAL TREATMENT. THE EVENT HIGH IOP WAS RESOLVED. THE CURRENT CONDITION OF SECONDARY GLAUCOMA WAS UNKNOWN.

  Patient problems: Glaucoma; Intraocular Pressure Increased

  MAUDE report 21353906 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN REPORTED THAT DURING VITRECTOMY, VITREOUS PUNCTURE INJECTION, RETINAL LASER PHOTOCOAGULATION, COMPLEX RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY FOR LEFT EYE, THE PATIENT EXPERIENCED MILD INCREASED INTRAOCULAR PRESSURE AND UNDERWENT AN ADDITIONAL MEDICAL TREATMENT. THE CURRENT CONDITION OF THE PATIENT WAS RESOLVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 21341921 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN REPORTED THAT DURING VITRECTOMY, INTRAVITREAL INJECTION, ANTERIOR MEMBRANE PEELING FOR COMPLEX RETINAL DETACHMENT REPAIR, RETINAL LASER PHOTOCOAGULATION, GAS INTERNAL PRESSURE SURGERY FOR RIGHT EYE, THE PATIENT EXPERIENCED HIGH INTRAOCULAR PRESSURE (IOP) WHICH WAS MILD INITIALLY AND IT WAS WORSENED TO MODERATE. AFTER UNDERGOING ADDITIONAL MEDICAL TREATMENT HIGH IOP WAS RESOLVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 21312052 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL VIA STUDY REPORTED THAT AFTER VITRECTOMY SURGERY, THE PATIENT EXPERIENCED HIGH INTRAOCULAR PRESSURE (AROUND 31MMHG) IN THE LEFT EYE. THE SEVERITY OF THE EVENT WAS MILD. THE PATIENT RECEIVED DRUG TREATMENT AND RESOLVED FROM THE EVENT.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 21251239 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL VIA STUDY REPORTED THAT AFTER VITRECTOMY SURGERY, THE PATIENT EXPERIENCED HIGH INTRAOCULAR PRESSURE IN THE RIGHT EYE. THE SEVERITY OF THE EVENT WAS MILD. THE PATIENT RECEIVED DRUG TREATMENT. THE CURRENT CONDITION OF THE PATIENT WAS UNKNOWN.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 21168777 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER VITRECTOMY SURGERY, THE PATIENT EXPERIENCED HIGH INTRAOCULAR PRESSURE IN THE RIGHT EYE. THE SEVERITY OF THE EVENT WAS MILD. THE PATIENT RECEIVED DRUG TREATMENT.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 20817263 ↗
• MalfunctionJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY, CATARACT PHACOEMULSIFICATION, INTRAOCULAR LENS IMPLANTATION, VITRECTOMY INJECTION, RETINAL LASER PHOTOCOAGULATION, PRE MEMBRANE STRIPPING FOR COMPLEX RETINAL DETACHMENT REPAIR, GAS COMPRESSION SURGERY ON THE RIGHT EYE PATIENT EXPERIENCED INTRAOCULAR HYPERTENSION (26 MMHG). PATIENT WAS TREATED WITH DRUG AND SYMPTOMS WERE RESOLVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 19459233 ↗
• InjuryMay 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A HEALTH CARE PROFESSIONAL REPORTED THAT, THE PATIENT EXPERIENCED HIGH INTRAOCULAR PRESSURE (39MMHG) IN THE LEFT EYE AFTER VITRECTOMY, VITRECTOMY INJECTION, RETINAL LASER PHOTOCOAGULATION, PRE RETINAL MEMBRANE STRIPPING AND GAS COMPRESSION SURGERY. IT WAS ALSO REPORTED THAT MIGHT BE RELATED TO CONSIDERING THE POSSIBLE INCREASE IN INTRAOCULAR PRESSURE CAUSED BY GAS EXPANSION OR TRANSIENT ANGLE OBSTRUCTION CAUSED BY ANTERIOR DISPLACEMENT OF THE LENS (ARTIFICIAL) AND IRIS DURING POSTOPERATIVE PATIENT SITTING POSITION, WHICH REQUIRED MEDICAL TREATMENT. THE CURRENT CONDITION OF THE PATIENT WAS RECOVERED FROM THE REPORTED EVENTS.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 19319641 ↗
• InjuryMay 8, 2024Restricted Flow rate; Restricted Flow rate

  A CASE STUDY OF AN OPHTHALMIC GAS USED FOR THE VITRECTOMY, CATARACT PHACOEMULSIFICATION SUCTION, INTRAOCULAR LENS IMPLANTATION, VITRECTOMY INJECTION, PRE MEMBRANE PEELING FOR COMPLEX RETINAL DETACHMENT REPAIR, RETINAL LASER PHOTOCOAGULATION, COMPLEX RETINAL DETACHMENT PRESSURE REPAIR, COMPLEX RETINAL DETACHMENT REPAIR SURGERY ON THE RIGHT EYE OF THE PATIENT REVEALED THAT THE PATIENT EXPERIENCED HIGH INTRAOCULAR PRESSURE. INCREASE IN INTRAOCULAR PRESSURE MIGHT BE RELATED TO GAS EXPANSION OR TRANSIENT ANGLE OBSTRUCTION CAUSED BY ANTERIOR DISPLACEMENT OF THE LENS AND IRIS DURING POSTOPERATIVE PATIENT SITTING POSITION.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 19267127 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED THAT PATIENT SYMPTOMS ARE RESOLVED. THE INITIAL DECISION TO REPORT WAS INCORRECT RESULTING IN THE INITIAL REPORT WITH EVENT DECLINE IN VISION BEING SUBMITTED IN ERROR. THIS EVENT DECLINE IN VISION IS NOT CONSIDERED TO BE ACTUAL EVENT. HENCE, IT WAS DELETED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Retinal Detachment; Retinal Tear; Visual Disturbances

  MAUDE report 18157564 ↗
• InjurySep 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CLINICAL STUDY STATED THAT HIGH INTRAOCULAR PRESSURE WAS HIGH AND FLASHES IN RIGHT EYE BECAUSE OF POSSIBLE INCREASE IN INTRAOCULAR PRESSURE CAUSED BY GAS EXPANSION. PATIENT WAS PRESCRIBED WITH MEDICATION AND SYMPTOMS RESOLVED.

  Patient problems: Flashers; Intraocular Pressure Increased

  MAUDE report 17696006 ↗