Clareon PanOptix Pro PXYWT0 (REF PXYWT0.205)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON PANOPTIX PRO · Class 3 · Implant
All models of Clareon PanOptix Pro (222)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380658411060), received between Jan 8, 2026 and Sep 18, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Deliver” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Failure to Deliver1
Patient problems
- Blurred Vision2
- Eye Irritation1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
A facility representative reported that following an intraocular lens (IOL) implantation procedure, the patient experienced visual phenomena, including glare, halos, and blurry vision. The lens was explanted and replaced with an unspecified monofocal intraocular lens during a secondary surgical procedure. The clinical reason for explantation were reported as dysphotopia and visual side effects.Additional information has been requested.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 50814628 ↗MalfunctionAug 31, 2026Failure to Deliver
A non health care professional reported that, during intraocular lens implantation surgery, The haptic was stuck to the cartridge and there was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525503 ↗InjuryJan 8, 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 VISION. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS MODEL 3 MONTHS AND 8 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS ASTHENOPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Eye Irritation
MAUDE report 24003888 ↗
Other Lens, Multifocal Intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 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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