ClareonRecalls & reported problems across all models
Alcon Laboratories, Inc. · 1,142 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8,100
- Deaths reported
- 0
- Injuries reported
- 2,771
- Recalls
- 1
We found 1,142 models of Clareon by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 8,100 adverse event reports in the FDA's MAUDE database, received between Aug 11, 2021 and Sep 30, 2026 — classified as 2,771 injuries, 5,329 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (920 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
Clareon 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.
- May 11, 2022Terminated
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
Z-1269-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported Clareon problems
Device problems
- Adverse Event Without Identified Device or Use Problem2,224
- Scratched Material920
- Break628
- Device Difficult to Setup or Prepare536
- Failure to Deliver472
- Defective Device411
- Material Twisted/Bent397
- Failure to Eject372
Patient problems
- Insufficient Information3,251
- No Clinical Signs, Symptoms or Conditions2,405
- Blurred Vision1,515
- Visual Impairment1,045
- Visual Disturbances832
- Halo238
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available84
- Corneal Edema82
Clareon models
1,142 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Clareon™ CNA0T0Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Lens, multifocal intraocular93 reports
- Clareon™ CNA0T0Lens, multifocal intraocular88 reports
- Clareon SY60WFintraocular lens84 reports
- Clareon SY60WFintraocular lens82 reports
- Clareon SY60WFintraocular lens78 reports
- Clareon™ CNA0T0Lens, multifocal intraocular1 recall27 reports
- Clareon™ CNA0T0Lens, multifocal intraocular75 reports
- Clareon™ CNA0T0Lens, multifocal intraocular73 reports
- Clareon SY60WFintraocular lens68 reports
- Clareon™ CNA0T0Lens, multifocal intraocular68 reports
- Clareon™ CC60WFintraocular lens68 reports
- Clareon™ CC60WFintraocular lens67 reports
- Clareon SY60WFintraocular lens63 reports
- Clareon SY60WFintraocular lens62 reports
- Clareon™ CC60WFintraocular lens62 reports
- Clareon SY60WFintraocular lens61 reports
- Clareon™ CNA0T0Lens, multifocal intraocular59 reports
- Clareon™ CNA0T0Lens, multifocal intraocular59 reports
- Clareon SY60WFintraocular lens58 reports
- Clareon™ CC60WFintraocular lens58 reports
- Clareon™ CC60WFintraocular lens52 reports
- Clareon CCWTT0intraocular lens52 reports
- Clareon™ CC60WFintraocular lens51 reports
- Clareon CCWTT0intraocular lens50 reports
- Clareon™ CC60WFintraocular lens49 reports
- Clareon CCWTT0intraocular lens49 reports
- Clareon CCWTT0intraocular lens48 reports
- Clareon SY60WFintraocular lens47 reports
- Clareon SY60WFintraocular lens45 reports
- Clareon™ CNA0T0Lens, multifocal intraocular44 reports
- Clareon™ CNA0T0Lens, multifocal intraocular43 reports
- Clareon CNWTT0LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon™ CCA0T0intraocular lens41 reports
- Clareon SY60WFintraocular lens40 reports
- Clareon™ CC60WFintraocular lens39 reports
- Clareon™ CCA0T0intraocular lens39 reports
- Clareon SY60WFintraocular lens38 reports
- Clareon™ CCA0T0intraocular lens38 reports
- Clareon CCWTT0intraocular lens38 reports
- Clareon™ CC60WFintraocular lens37 reports
- Clareon CCWTT0intraocular lens37 reports
- Clareon™ CC60WFintraocular lens36 reports
- Clareon CNWTT0LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CCWTT0intraocular lens35 reports
- Clareon CCWTT0intraocular lens35 reports
- Clareon CCWTT0intraocular lens34 reports
- Clareon CCWET0intraocular lens32 reports
- Clareon CCWET0intraocular lens32 reports
- Clareon CNWTT0LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Lens, multifocal intraocular32 reports
- Clareon™ CNA0T0Lens, multifocal intraocular31 reports
- Clareon CCWET0intraocular lens31 reports
- Clareon CCWTT0intraocular lens31 reports
- Clareon™ CC60WFintraocular lens30 reports
- Clareon CNWTT0LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon™ CC60WFintraocular lens29 reports
- Clareon™ CCA0T0intraocular lens29 reports
- Clareon CNWTT0LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon™ CNA0T0Lens, multifocal intraocular28 reports
- Clareon™ CCA0T0intraocular lens28 reports
- Clareon™ CCA0T0intraocular lens28 reports
- Clareon SY60WFintraocular lens27 reports
- Clareon™ CCA0T0intraocular lens27 reports
- Clareon™ CCA0T0intraocular lens26 reports
- Clareon CCWET0intraocular lens26 reports
- Clareon CCWET0intraocular lens26 reports
- Clareon CNWTT0Lens, multifocal intraocular26 reports
- Clareon CNWTT0Lens, multifocal intraocular26 reports
- Clareon™ CC60WFintraocular lens25 reports
- Clareon™ CCA0T0intraocular lens25 reports
- Clareon™ CCA0T0intraocular lens25 reports
- Clareon CNWTT0Lens, multifocal intraocular24 reports
- Clareon CCWTT3intraocular lens24 reports
- Clareon SY60WFintraocular lens23 reports
- Clareon CCWET0intraocular lens23 reports
- Clareon CNWTT0Lens, multifocal intraocular23 reports
- Clareon CCWET3intraocular lens22 reports
- Clareon SY60WFintraocular lens21 reports
- Clareon™ CNA0T0Lens, multifocal intraocular21 reports
- Clareon™ CNA0T0Lens, multifocal intraocular21 reports
- Clareon™ CC60WFintraocular lens21 reports
- Clareon CCWET0intraocular lens21 reports
- Clareon CCWET0intraocular lens21 reports
- Clareon CNWTT0LENS, INTRAOCULAR, TORIC OPTICS21 reports
- Clareon CCWTT0intraocular lens21 reports
- Clareon CCWTT3intraocular lens21 reports
- Clareon CCWTT3intraocular lens21 reports
- Clareon SY60WFintraocular lens20 reports
- Clareon™ CNA0T0Lens, multifocal intraocular20 reports
- Clareon™ CC60WFintraocular lens20 reports
- Clareon™ CCA0T0intraocular lens20 reports
- Clareon CNWET0intraocular lens20 reports
- Clareon CNWET0intraocular lens20 reports
Recent Clareon adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Opacification
A non-healthcare professional reported after intraocular lens (IOL) implant procedure, the lens is white and cloudy.Additional information was requested and received stating that no subjective symptoms were associated with this finding. No plan for replacing IOL.
Patient problems: Insufficient Information
MAUDE report 50948919 ↗MalfunctionSep 30, 2026Break
A non-healthcare professional reported that during an intraocular lens (IOL) implant procedure, the IOL was observed with a chunk missing after it was injected through the injector. The originally scheduled procedure was completed, and the lens was left inside the eye and centered. There was no patient harm.Additional information was requested but was not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945902 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
A healthcare professional reported during intraocular lens (IOL) implant procedure, the surgeon noticed optical part of IOL had cracks after the IOL was implanted into the eye. The lens was explanted during initial procedure. The procedure was completed on same day. There was no patient harm.Additional information received via regulatory agency stating that the IOL appeared normal, with no abnormality observed by the naked eye. After implantation into the patient's eye, a distinct scratch was observed in the central area of the IOL under the microscope and procedure was completed by using another unspecified lens.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945173 ↗MalfunctionSep 30, 2026Dent in Material
A health care professional reported that during cataract surgery with intraocular lens (IOL) implantation, a stripe was observed on the lens optic after it was implanted. Consequently, the implanted lens was removed, and another lens was placed during the same surgery. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50943064 ↗MalfunctionSep 29, 2026Material Opacification
A physician reported that, one day after cataract surgery with intraocular lens (IOL) implantation, the lens was observed to be white and cloudy. There were no subjective symptoms associated with this event. The lens remains implanted.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 50933533 ↗MalfunctionSep 29, 2026Failure to Deliver
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the lens was stuck in the injector. It was unknown if the originally scheduled surgery was completed. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50933049 ↗MalfunctionSep 29, 2026Material Twisted/Bent
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, that the haptic was deformed/asymmetric. Surgeon opened back up lens and originally scheduled procedure was completed on the same day. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50933047 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
A surgeon reported that following an intraocular lens (IOL) implant procedure, the patient experienced an inflammatory reaction approximately one week after implantation, with inability of the iris to dilate normally, accompanied by photophobia and discomfort when transitioning from light to dark environments and vice versa. The reaction was diagnosed by the treating physician as iritis and was managed with anti-inflammatory treatment. The surgeon suspected a potential issue related to the lens material and requested further investigation.Additional information has been requested and received stating that that anti-inflammatory treatment, including a fluoroquinolone antibiotic plus corticosteroid, a non-steroidal anti-inflammatory drug, and a corticosteroid (glucocorticoid). No explantation procedure was performed. The patient had not returned for a follow-up visit, as the patient chose to continue care with another healthcare professional. No information was available regarding the patient¿s current condition.
Patient problems: Eye Injury; Eye Irritation; Uveitis; Visual Disturbances
MAUDE report 50932707 ↗MalfunctionSep 29, 2026Failure to Advance; Device Damaged by Another Device
A nurse reported that during an intraocular lens (IOL) implant procedure, plunger went through the IOL and the IOL was damaged. The surgery was completed on the same day by using a replacement lens. There was no patient harm.Additional information was received and stated, there was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931166 ↗MalfunctionSep 29, 2026Failure to Deliver
A nonhealth care professional reported that during the intraocular lens (IOL) implantation surgery, the lens was coiled. Additional information was received stating that, the issue was noticed when deploying the lens and the lens made contact with the eye but it was not implanted. In the surgeon's opinion, the lens was not made properly caused or contributed to the event. The surgery was completed on the same day and there was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930864 ↗MalfunctionSep 28, 2026Material Twisted/Bent
A facility Representative reported that during an intraocular lens (IOL) implantation procedure, trailing haptic was bent. Additional information has been received stating the device tip did not come in contact with the patient's eye. The procedure was completed on the same day.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922200 ↗MalfunctionSep 28, 2026Device Difficult to Setup or Prepare
A non-healthcare professional reported that during an intraocular lens (IOL) implantation procedure, lens trailing haptic was stuck in the wound, incision was small for the device to enter. The lens was removed during the initial procedure. The procedure was completed on the same day using the backup lens.
Patient problems: Insufficient Information
MAUDE report 50921267 ↗MalfunctionSep 28, 2026Failure to Fold
A Nonhealthcare professional reported with description of lens did not unload properly.Additional information has been requested, yet no new information received.
Patient problems: Insufficient Information
MAUDE report 50916283 ↗MalfunctionSep 28, 2026Material Deformation
Patient problems: Insufficient Information
MAUDE report 50915645 ↗MalfunctionSep 28, 2026Break
A non health care professional reported that the haptic was broken when it was being loaded into the cartridge.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 50915644 ↗
Other Alcon Laboratories, Inc. products
- 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
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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