AcrySof UltraSertRecalls & reported problems across all models
Alcon Laboratories, Inc. · 102 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,467
- Deaths reported
- 0
- Injuries reported
- 123
- Recalls
- 1
We found 102 models of AcrySof UltraSert by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 1,467 adverse event reports in the FDA's MAUDE database, received between Aug 17, 2016 and Sep 30, 2026 — classified as 123 injuries, 1,344 malfunctions.
The most frequently reported specific device problem is “Failure to Eject” (269 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
AcrySof UltraSert recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 17, 2020Class IITerminated
Incorrect IOL diopter
Z-2287-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported AcrySof UltraSert problems
Device problems
- Failure to Eject269
- Failure to Advance253
- Device Difficult to Setup or Prepare222
- Device Damaged by Another Device214
- Defective Device135
- Failure to Deliver95
- Break92
- Material Twisted/Bent80
Patient problems
- No Clinical Signs, Symptoms or Conditions787
- Insufficient Information591
- Capsular Bag Tear33
- Eye Injury30
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available22
- Blurred Vision11
- Visual Impairment10
- Corneal Edema9
AcrySof UltraSert models
102 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- AcrySof® UltraSert® AU00T0intraocular lens1 recall49 reports
- AcrySof® UltraSert® AU00T0intraocular lens89 reports
- AcrySof® UltraSert® AU00T0intraocular lens85 reports
- AcrySof® UltraSert® AU00T0intraocular lens74 reports
- AcrySof® UltraSert® AU00T0intraocular lens65 reports
- AcrySof® UltraSert® AU00T0intraocular lens60 reports
- AcrySof® UltraSert® AU00T0intraocular lens54 reports
- AcrySof® UltraSert® ACU0T0intraocular lens49 reports
- AcrySof® UltraSert® ACU0T0intraocular lens46 reports
- AcrySof® UltraSert® ACU0T0intraocular lens44 reports
- AcrySof® UltraSert® ACU0T0intraocular lens43 reports
- AcrySof® UltraSert® AU00T0intraocular lens41 reports
- AcrySof® UltraSert® ACU0T0intraocular lens39 reports
- AcrySof® UltraSert® ACU0T0intraocular lens37 reports
- AcrySof® UltraSert® AU00T0intraocular lens35 reports
- AcrySof® UltraSert® AU00T0intraocular lens29 reports
- AcrySof® UltraSert® AU00T0intraocular lens27 reports
- AcrySof® UltraSert® AU00T0intraocular lens27 reports
- AcrySof® UltraSert® ACU0T0intraocular lens27 reports
- AcrySof® UltraSert® ACU0T0intraocular lens27 reports
- AcrySof® UltraSert® ACU0T0intraocular lens24 reports
- AcrySof® UltraSert® AU00T0intraocular lens23 reports
- AcrySof® UltraSert® AU00T0intraocular lens22 reports
- AcrySof® UltraSert® ACU0T0intraocular lens22 reports
- AcrySof® UltraSert® ACU0T0intraocular lens22 reports
- AcrySof® UltraSert® AU00T0intraocular lens20 reports
- AcrySof® UltraSert® AU00T0intraocular lens19 reports
- AcrySof® UltraSert® ACU0T0intraocular lens19 reports
- AcrySof® UltraSert® ACU0T0intraocular lens18 reports
- AcrySof® UltraSert® ACU0T0intraocular lens16 reports
- AcrySof® UltraSert® AU00T0intraocular lens15 reports
- AcrySof® UltraSert® ACU0T0intraocular lens15 reports
- AcrySof® UltraSert® AU00T0intraocular lens14 reports
- AcrySof® UltraSert® ACU0T0intraocular lens13 reports
- AcrySof® UltraSert® AU00T0intraocular lens12 reports
- AcrySof® UltraSert® ACU0T0intraocular lens12 reports
- AcrySof® UltraSert® ACU0T0intraocular lens12 reports
- AcrySof® UltraSert® AU00T0intraocular lens11 reports
- AcrySof® UltraSert® AU00T0intraocular lens11 reports
- AcrySof® UltraSert® ACU0T0intraocular lens11 reports
- AcrySof® UltraSert® AU00T0intraocular lens10 reports
- AcrySof® UltraSert® AU00T0intraocular lens9 reports
- AcrySof® UltraSert® AU00T0intraocular lens9 reports
- AcrySof® UltraSert® ACU0T0intraocular lens9 reports
- AcrySof® UltraSert® ACU0T0intraocular lens7 reports
- AcrySof® UltraSert® ACU0T0intraocular lens7 reports
- AcrySof® UltraSert® AU00T0intraocular lens6 reports
- AcrySof® UltraSert® AU00T0intraocular lens6 reports
- AcrySof® UltraSert® ACU0T0intraocular lens6 reports
- AcrySof® UltraSert® ACU0T0intraocular lens6 reports
- AcrySof® UltraSert® ACU0T0intraocular lens6 reports
- AcrySof® UltraSert® AU00T0intraocular lens5 reports
- AcrySof® UltraSert® AU00T0intraocular lens5 reports
- AcrySof® UltraSert® ACU0T0intraocular lens5 reports
- AcrySof® UltraSert® ACU0T0intraocular lens5 reports
- AcrySof® UltraSert® AU00T0intraocular lens4 reports
- AcrySof® UltraSert® AU00T0intraocular lens4 reports
- AcrySof® UltraSert® AU00T0intraocular lens4 reports
- AcrySof® UltraSert® ACU0T0intraocular lens4 reports
- AcrySof® UltraSert® ACU0T0intraocular lens4 reports
- AcrySof® UltraSert® ACU0T0intraocular lens4 reports
- AcrySof® UltraSert® ACU0T0intraocular lens4 reports
- AcrySof® UltraSert® ACU0T0intraocular lens4 reports
- AcrySof® UltraSert® AU00T0intraocular lens3 reports
- AcrySof® UltraSert® AU00T0intraocular lens3 reports
- AcrySof® UltraSert® AU00T0intraocular lens3 reports
- AcrySof® UltraSert® ACU0T0intraocular lens3 reports
- ACRYSOF ULTRASERT AU00T0intraocular lens2 reports
- ACRYSOF ULTRASERT AU00T0intraocular lens2 reports
- AcrySof® UltraSert® AU00T0intraocular lens2 reports
- AcrySof® UltraSert® AU00T0intraocular lens2 reports
- AcrySof® UltraSert® AU00T0intraocular lens2 reports
- AcrySof® UltraSert® AU00T0intraocular lens2 reports
- AcrySof® UltraSert® AU00T0intraocular lens2 reports
- AcrySof® UltraSert® ACU0T0intraocular lens2 reports
- AcrySof® UltraSert® ACU0T0intraocular lens2 reports
- ACRYSOF ULTRASERT AU00T0intraocular lens1 report
- ACRYSOF ULTRASERT AU00T0intraocular lens1 report
- ACRYSOF ULTRASERT AU00T0intraocular lens1 report
- ACRYSOF ULTRASERT AU00T0intraocular lens1 report
- ACRYSOF ULTRASERT AU00T0intraocular lens1 report
- ACRYSOF ULTRASERT AU00T0intraocular lens1 report
- AcrySof® UltraSert® AU00T0intraocular lens1 report
- AcrySof® UltraSert® AU00T0intraocular lens1 report
- AcrySof® UltraSert® AU00T0intraocular lens1 report
- AcrySof® UltraSert® AU00T0intraocular lens1 report
- AcrySof® UltraSert® AU00T0intraocular lens1 report
- AcrySof® UltraSert® AU00T0intraocular lens1 report
- AcrySof® UltraSert® AU00T0intraocular lens1 report
- AcrySof® UltraSert® ACU0T0intraocular lens1 report
- AcrySof® UltraSert® ACU0T0intraocular lens1 report
- AcrySof® UltraSert® ACU0T0intraocular lens1 report
- AcrySof® UltraSert® ACU0T0intraocular lens1 report
- AcrySof® UltraSert® ACU0T0intraocular lens1 report
- AcrySof® UltraSert® ACU0T0intraocular lens1 report
- AcrySof® UltraSert® ACU0T0intraocular lens1 report
- AcrySof® UltraSert® ACU0T0intraocular lens1 report
- AcrySof® UltraSert® ACU0T0intraocular lens1 report
- AcrySof® UltraSert® ACU0T0intraocular lens1 report
- AcrySof® UltraSert® ACU0T0intraocular lens1 report
Recent AcrySof UltraSert adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Difficult to Setup or Prepare
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, trailing haptic was stuck to the plunger, preventing implantation into the eye. The lens was replaced with a new one and functioned normally. The tip of the pre-loaded device was not in contact with the patient eye.Additional information has been requested but is not available at the time of this report.There are seven medical reports associated with same event. This file is 7 of 7.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948065 ↗MalfunctionSep 30, 2026Device Difficult to Setup or Prepare
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, trailing haptic was stuck to the plunger, preventing implantation into the eye. The lens was replaced with a new one and functioned normally. The tip of the pre-loaded device was not in contact with the patient eye.Additional information has been requested but is not available at the time of this report.There are seven medical reports associated with same event. This file is 5 of 7.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948033 ↗MalfunctionSep 30, 2026Device Difficult to Setup or Prepare
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, trailing haptic was stuck to the plunger, preventing implantation into the eye. The lens was replaced with a new one and functioned normally. The tip of the pre-loaded device was not in contact with the patient eye.Additional information has been requested but is not available at the time of this report.There are seven medical reports associated with same event. This file is 3 of 7.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948032 ↗MalfunctionSep 30, 2026Device Difficult to Setup or Prepare
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, trailing haptic was stuck to the plunger, preventing implantation into the eye. The lens was replaced with a new one and functioned normally. The tip of the pre-loaded device was not in contact with the patient eye.Additional information has been requested but is not available at the time of this report.There are seven medical reports associated with same event. This file is 1 of 7.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948029 ↗MalfunctionSep 30, 2026Device Difficult to Setup or Prepare
A healthcare professional reported that during an intraocular lens (IOL) implantation procedure, the lens was very stiff to push while advancing the plunger. As a result, the lens was not used, although it had patient contact. The surgery was completed on the same day using another lens, without any harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946538 ↗MalfunctionSep 29, 2026Material Discolored
A healthcare professional reported that, following intraocular lens (IOL) implantation surgery, a diffuse coating was observed on the anterior surface of the patient's IOL; however, it was not considered visually significant. Additional information has been requested but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50934274 ↗MalfunctionSep 29, 2026Failure to Deliver
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, lens was failed to advance. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50933041 ↗MalfunctionSep 28, 2026Material Twisted/Bent
A health care professional reported that during an intraocular lens (IOL) implantation procedure, twisted loop. There was no patient contact. The procedure was completed on the same day.Additional information has been requested but is not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921264 ↗MalfunctionSep 28, 2026Material Twisted/Bent
A health care professional reported that during an intraocular lens (IOL) implantation procedure, twisted loop. There was no patient contact. The procedure was completed on the same day.Additional information has been requested but is not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915641 ↗MalfunctionSep 28, 2026Material Twisted/Bent
A health care professional reported that during an intraocular lens (IOL) implant procedure, trailing haptic remained straight during injection and could not be placed into the eye, which required opening a new intraocular lens.Additional information has been requested but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50914303 ↗MalfunctionSep 26, 2026Device Difficult to Setup or Prepare
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907628 ↗MalfunctionSep 26, 2026Device Difficult to Setup or Prepare
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907627 ↗MalfunctionSep 26, 2026Device Difficult to Setup or Prepare
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907619 ↗MalfunctionSep 26, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50906911 ↗MalfunctionSep 25, 2026Device Difficult to Setup or Prepare
A Facility representative reported that during Intraocular lens (IOL) implantation lens did not load into injector.Additional information has been requested, yet no new information received.
Patient problems: Insufficient Information
MAUDE report 50899132 ↗
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
- MONARCH III2 models · 1,380 reports · 1 recall
- ClearCut17 models · 531 reports · 13 recalls
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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