Clareon PanOptix Pro PXCAT4 (REF PXCAT4.220)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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380658491857), received between May 4, 2026 and Sep 15, 2026 — classified as 3 malfunctions.
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
- Inaccurate Delivery1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Device Difficult to Setup or Prepare
A non health care professional reported that during an intraocular lens (IOL) implant procedure, lens was advancing despite trying to stop it prior to lens implantation.Additional information was requested and received, stating that upon attempting to insert the lens through the incision, it was determined that the lens had advanced too far to remain stable and became completely exposed from the delivery system, getting stuck at the tip. During preparation, the lens continued to advance despite the scrub technician's attempts to stop it. The tip of the injector, with the exposed lens, touched the eye but did not enter the capsular bag. Surgery was completed by using back up lens without any harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774807 ↗MalfunctionJul 13, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 25795717 ↗MalfunctionMay 4, 2026Inaccurate Delivery
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, HAD ISSUE WITH DEPLOYMENT AND WHEN IMPLANTED IT POPPED OUT. LENS WAS NEVER COMPLETELY INSERTED. HALF-IN-A-HALF-OUT AND PATIENT HAD NO HARM. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071748 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page