Clareon PanOptix Pro PXYAT0 (REF PXYAT0.185)Recalls & reported problems
Alcon Laboratories, Inc. · CL PANOPTIX PRO ATME BLF · Class 3 · Implant
All models of Clareon PanOptix Pro (222)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380658493257), received between Jan 5, 2026 and Aug 27, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Deformation1
Patient problems
- Blurred Vision1
- Inflammation1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Material Deformation
A physician reported that following intraocular lens (IOL) implantation procedure, the patient experienced a sensation like an oily film covering the lens. The lens was replaced with unspecified lens.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50471047 ↗InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED UNDERGOING CATARACT SURGERY IN BOTH EYES IN (B)(6) 2025. THE LEFT EYE RECOVERED WELL, BUT HE EXPERIENCED ISSUES WITH THE RIGHT EYE. FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE, HE NOTED THAT HIS VISION WAS NOT AS GOOD - HE COULD SEE WELL FOR ALL THINGS EXCEPT NEAR. HIS SURGEON ADVISED HIM TO CONTINUE USING CORTICOSTEROID EYE DROPS TO MANAGE OCULAR INFLAMMATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Inflammation
MAUDE report 23957357 ↗
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 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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