Clareon PanOptix Pro PXYAT3 (REF PXYAT3.210)Recalls & reported problems
Alcon Laboratories, Inc. · CLRN PO PRO TORIC 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380658494285), received between Nov 19, 2025 and Sep 25, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (2 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, 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
- Device Difficult to Setup or Prepare2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionNov 19, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THE TOP HAPTIC OF PRE-LOADED LENS WAS BACKWARDS AND DID NOT ADVANCE CORRECTLY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23591119 ↗
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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