ISPANRecalls & reported problems across all models
Alcon Laboratories, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 222
- Deaths reported
- 0
- Injuries reported
- 142
- Recalls
- 0
We found 8 models of ISPAN by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 222 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2021 and Apr 21, 2026 — classified as 142 injuries, 80 malfunctions.
The most frequently reported specific device problem is “Gas Output Problem” (53 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ISPAN problems
Device problems
- Adverse Event Without Identified Device or Use Problem132
- Gas Output Problem53
- Appropriate Device Problem Term/Code Not Available18
- Failure to Deliver9
- Short Fill8
- Gas/Air Leak5
- Defective Component2
- No Flow2
Patient problems
- No Clinical Signs, Symptoms or Conditions71
- Intraocular Pressure Increased69
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available40
- Glaucoma37
- Retinal Detachment12
- Insufficient Information6
- Visual Impairment5
- Cataract4
ISPAN models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ISPAN 8065797102Gases Used Within Eye To Place Pressure On Detached Retina84 reports
- ISPAN 8065797303REGULATOR, PRESSURE, GAS CYLINDER56 reports
- ISPAN 8065797103Gases Used Within Eye To Place Pressure On Detached Retina38 reports
- ISPAN 8065797105Gases Used Within Eye To Place Pressure On Detached Retina23 reports
- ISPAN 8065797005Gases Used Within Eye To Place Pressure On Detached Retina10 reports
- ISPAN 8065797002Gases Used Within Eye To Place Pressure On Detached Retina9 reports
- ISPAN 8065797004Gases Used Within Eye To Place Pressure On Detached Retina1 report
- ISPAN 8065797101Gases Used Within Eye To Place Pressure On Detached Retina1 report
Recent ISPAN adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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