Clareon PanOptix ProRecalls & reported problems across all models
Alcon Laboratories, Inc. · 222 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 446
- Deaths reported
- 0
- Injuries reported
- 235
- Recalls
- 0
We found 222 models of Clareon PanOptix Pro by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 446 adverse event reports in the FDA's MAUDE database, received between Jun 2, 2025 and Sep 29, 2026 — classified as 235 injuries, 211 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (66 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 Clareon PanOptix Pro problems
Device problems
- Adverse Event Without Identified Device or Use Problem214
- Device Difficult to Setup or Prepare66
- Failure to Deliver30
- Scratched Material27
- Material Twisted/Bent25
- Break19
- Failure to Advance18
- Product Quality Problem12
Patient problems
- Blurred Vision140
- Insufficient Information127
- No Clinical Signs, Symptoms or Conditions102
- Visual Disturbances102
- Visual Impairment68
- Eye Irritation6
- Dry Eye(s)5
- Diplopia/Double Vision3
Clareon PanOptix Pro models
222 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular10 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular9 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular9 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular8 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular8 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular8 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular6 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular6 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular5 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular5 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular5 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular5 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular5 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular5 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular5 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXYAT3Lens, Multifocal Intraocular4 reports
- Clareon PanOptix Pro PXYWT0Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXCWT0Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXCWT0Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXCWT0Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXCWT0Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXCAT4Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXCAT4Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXCAT4Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXCAT6Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXYAT3Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXYAT3Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXYAT3Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXYAT4Lens, Multifocal Intraocular3 reports
- Clareon PanOptix Pro PXYWT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYWT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCWT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCWT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCWT4Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYWT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYWT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYWT4Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT4Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT4Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT4Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT4Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT4Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT4Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT5Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT5Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXCAT5Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT0Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT3Lens, Multifocal Intraocular2 reports
- Clareon PanOptix Pro PXYAT3Lens, Multifocal Intraocular2 reports
Recent Clareon PanOptix Pro adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Scratched Material
A healthcare professional reported that during an intraocular lens (IOL) implantation procedure, the central portion of the lens was observed to have a thin, U-shaped defect.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50933284 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
A non-healthcare professional reported that following an intraocular lens (IOL) implant procedure, the patient experienced blurry visual acuity. The clinical reason for explant was maladaptation. The IOL was exchanged for a non-company light adjustable lens (LAL) model 06 months and 05 days following the initial implant procedure. In the surgeon's opinion the product caused or contributed to the event.Additional information has been requested but is not available at the time of this report.
Patient problems: Blurred Vision
MAUDE report 50932883 ↗MalfunctionSep 29, 2026Material Twisted/Bent
A nonhealth care professional reported that during the intraocular lens (IOL) implantation surgery, the leading haptic was in wrong orientation. The surgeon used a back up lens to complete the surgery. There was no patient harm.Additional information has been requested but no information is available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929174 ↗MalfunctionSep 28, 2026Device Difficult to Setup or Prepare
A Facility Representative reported during intraocular lens (IOL) implant procedure, that the trailing haptic was folded wrong and the inserter was twisted. Procedure was completed on the same day and there was no patient contact.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 50915643 ↗MalfunctionSep 25, 2026Material Twisted/Bent
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, haptic was bent. Additional information has been received stating there was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898914 ↗MalfunctionSep 25, 2026Device Difficult to Setup or Prepare
A non-healthcare professional reported that during intraocular lens (IOL) implantation surgery, the IOL was unable to be used due to trailing haptic issue.According to the additional information received, the surgery was completed on the same day. There was no patient contact with the affected device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896951 ↗MalfunctionSep 25, 2026Failure to Advance
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, surgeon had an issue with two injectors on the same case. Both the devices were inoperable, so the surgeon manually loaded the second IOL and completed the surgery.Additional information has been received and stated, the plunger was pushed past the lens during the lens insertion into the eye and in surgeon¿s opinion this contributed to or caused the event. The procedure was completed on the same day and the second lens still remains implanted. There was no harm or complication to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894799 ↗MalfunctionSep 25, 2026Failure to Advance
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, surgeon had an issue with two injectors on the same case. Both the devices were inoperable, so the surgeon manually loaded the second IOL and completed the surgery.Additional information has been received and stated, the plunger was pushed past the lens during the lens insertion into the eye and in surgeon¿s opinion this contributed to or caused the event. The procedure was completed on the same day and the second lens still remains implanted. There was no harm or complication to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894798 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
A non-health care professional reported that following an intraocular lens (IOL) implantation procedure, the patient experienced blurry vision. Clinical reason being mentioned as refractive error despite using ASCRS (American Society of Cataract and Refractive Surgery) post-myopic LASIK (Laser-Assisted In Situ Keratomileusis) calculator. The IOL was explanted and exchanged for an unknown ATIOL (advanced technology intraocular lens) in the secondary implant procedure. Additional information has been received and stated, missed or errant refractive target (large myopic result)
Patient problems: Visual Impairment
MAUDE report 50894797 ↗MalfunctionSep 25, 2026Device Difficult to Setup or Prepare
A non-healthcare professional reported that during an intraocular lens (IOL) implant procedure, the plunger did not advance the lens.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50894264 ↗MalfunctionSep 24, 2026Failure to Deliver
A healthcare professional reported that, following advancement of the plunger, the trailing haptic became stuck with patient contact. The originally scheduled procedure was completed on the same day.
Patient problems: Insufficient Information
MAUDE report 50885992 ↗MalfunctionSep 24, 2026Device Difficult to Setup or Prepare
A healthcare professional reported that during an intraocular lens (IOL) implantation procedure, a defect was identified in the trailing haptic at the pause location after loading. The lens was replaced, and the procedure was completed using a replacement lens. 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 50885534 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
A non-health care professional reported that following an intraocular lens (IOL) implant procedure, the patient had myopia. The IOL was exchanged for unspecified Advanced Technology Intraocular Lens. Clinical reason for explant was mentioned as residual myopia.Additional information has been requested, yet no new information received.
Patient problems: Visual Impairment
MAUDE report 50884980 ↗InjurySep 24, 2026Break; Device Difficult to Setup or Prepare; Device Dislodged or Dislocated
A non-healthcare professional reported that following an intraocular lens (IOL) implant procedure, the patient did not experience any complaints. The clinical reason for explant was a broken IOL haptic due to loading issues, and the lens was not stable in the bag. The IOL was exchanged for an unspecified advanced technology intraocular lens (ATIOL) model following the initial implant procedure.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50883848 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
A consumer reported that following an intraocular lens (IOL) implant procedure, it was stated that the patient intermediate vision was 0.4 and unable to read the text on a computer screen. It was also stated that it was difficult to see objects at very close distances, and was experiencing eye tremors. Patient vision was blurry and unable to read computer screen clearly.Additional information has been requested but is not available at the time of this report.
Patient problems: Blurred Vision; Unspecified Eye / Vision Problem
MAUDE report 50882401 ↗
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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