Clareon PanOptix Pro PXYAT0 (REF PXYAT0.100)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380658493080), received between Nov 24, 2025 and Jul 28, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Fold” (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
- Failure to Fold1
- Scratched Material1
Patient problems
- Blurred Vision1
- Insufficient Information1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 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 glare/halos, can't drive at night or in rainy conditions. Additional information was received that carbachol (2.75%) and brimonidine tartrate (0.1%) in combination drops were prescribed as medication to help with glare and halos. The patient returned after a few days stating the drops might have been helping a little and was given the option of an IOL exchange vs continuing to give it more time to adapt. The patient wished to give it more time and scheduled her next appointment later. There are two Medical Device Reports associated with this patient. This report is associated with the left eye.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 50053647 ↗MalfunctionNov 24, 2025Failure to Fold; Scratched Material; Failure to Fold; Scratched Material
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE DEPLOYMENT THE LENS FOLDED BACKWARDS AND BOTH HAPTICS ON BACK OF IOL LIKE THE WHOLE LENS ROLLED DOWN INSTEAD OF UP AND ALSO A SMALL SCRATCH ON THE OUTERMOST RING OF THE LENS, OUTSIDE OF LAST ESCHELLETE BUT STILL USED THE LENS IN THE PATIENT DID NOT NEED TO EXPLANT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23630601 ↗
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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