Clareon PanOptix Pro PXCWT3 (REF PXCWT3.210)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON PANOPTIX PRO TORICUV · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380658433987), received between Jun 18, 2025 and Jun 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Dislodged or Dislocated1
Patient problems
- Blurred Vision1
- Conjunctivitis1
- Corneal Edema1
- Eye Pain1
- Inflammation1
- Intraocular Pressure Increased1
- Red Eye(s)1
- Toxic Anterior Segment Syndrome (TASS)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD TASS (TOXIC ANTERIOR SEGMENT SYNDROME) ONE DAY POST OP, WITH INFLAMMATION CONFINED TO THE ANTERIOR CHAMBER. UNSPECIFIED TOPICAL STEROIDS WERE STARTED AND FOLLOW UP HAS BEEN SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED TASS ONSET WAS SEEN A POST-OP DAY 1. CULTURES WERE NOT DONE. CONJUNCTIVAL INFLAMMATION, AQUEOUS CELLS AND AQUEOUS FIBRIN WERE PRESENT. POST OP DAY 6, THE PATIENT HAD EYE PAIN, TRACE CORNEAL EDEMA AND SCLERAL REDNESS. MEDICATION ADJUSTMENTS WERE MADE, NOTED POTENTIAL FOR SURGICAL INTERVENTION OF LENS ROTATION DUE TO BLURRY VISION FROM 031 DEGREE TO 180 DEGREE. INFLAMMATION & FIBRIN IMPROVING. (B)(6) 2025 VISIT VISUAL ACUITY 20/40, INTRAOCULAR PRESSURE WAS NOTED AS INCREASED AND TREATED TOPICALLY WITH UNSPECIFIED MEDICATION. ADDITIONALLY, SURGEON STATED THERE WAS NOTHING OUT OF THE ORDINARY OR SIGNIFICANT TO BE NOTED AS FAR AS THE SURGICAL PROCESS WAS CONCERNED. ALL STERILIZATION RECORDS WERE SUFFICIENT AND WITHIN PARAMETERS. NO BREAKS IN PROCESS OR POLICY WERE NOTED. SO FAR THIS REMAINS AN ISOLATED INSTANCE.
Patient problems: Blurred Vision; Conjunctivitis; Corneal Edema; Eye Pain; Inflammation; Intraocular Pressure Increased; Red Eye(s); Toxic Anterior Segment Syndrome (TASS)
MAUDE report 22283244 ↗
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