Clareon PanOptix Pro PXCAT6 (REF PXCAT6.240)Recalls & reported problems
Alcon Laboratories, Inc. · CLRN PO PRO TORIC ATME UVA · Class 3 · Implant
All models of Clareon PanOptix Pro (222)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380658492878), received between Dec 9, 2025 and Dec 9, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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
- Device Difficult to Setup or Prepare1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A SURGICAL TECHNICIAN REPORTED A DEFECTIVE LENS. IT WAS OPENED BUT NOT USED. THE ISSUE OCCURRED DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE REPORTED EVENT "DEFECTIVE LENS" WAS FURTHER DETAILED: THE LENS MALFUNCTIONED DURING LOADING - DURING INSERTION OF THE LENS, THE HAPTICS WERE CAUGHT IN THE LENS INSERTER. CONSEQUENTLY, THE LENS WAS NOT FULLY INSERTED INTO THE EYE, IT REMAINED PARTIALLY IN THE DELIVERY SYSTEM. ACCORDING TO THE SURGEON, THE EVENT WAS ATTRIBUTED TO A "COLD LENS" AND POSSIBLY TECHNICIAN ERROR. THE TECHNICIAN MIGHT HAVE PARTIALLY TRIGGERED DEPLOYMENT WITH FIRST CLICK OF INSERTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT LENS DURING THE SAME SURGERY, AND THE SURGEON REPORTED AN EXCELLENT PROGNOSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23757335 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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