Clareon CCWTT5 (UDI 00380652458429)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon PanOptix Toric UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652458429), received between Apr 1, 2024 and Dec 31, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Device Dislodged or Dislocated1
- Scratched Material1
Patient problems
- Halo2
- Insufficient Information1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED INTOLERABLE HALOS AND NOTICED RINGS AROUND LIGHTS. CLINICAL REASON WAS MENTIONED AS PATIENT WAS UNABLE TO TOLERATE THE LENS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE.
Patient problems: Halo; Visual Disturbances
MAUDE report 21047033 ↗MalfunctionNov 21, 2024Break; Scratched Material; Break; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAD AN AMPUTATED HAPTIC AND LENS WAS SCRATCHED, NOTED UPON INSERTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20742919 ↗MalfunctionMay 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PHYSICIAN REPORTED THAT A 65 YEAR OLD AF HAD 2.31 D OF CORNEAL ASTIGMATISM AT 116 DEGREE ON LENSTAR MEASUREMENT AND 1.92 D AT 118 DEGREES ON TOPOGRAPHY. USING ALCON TORIC CALCULATOR, A COMPANY LENS WAS RECOMMENDED WITH AN IMPLANTED AXIS OF 118 DEGREES. LENS WAS IMPLANTED WITH AN AXIS OF 115 DEGREES. ON SLE, THE IOL APPEARS TO BE ORIENTED AT ABOUT 110 DEGREES. POST OPERATIVELY, THE PATIENT HAS A REFRACTION OF -075+150X160 WITH A VISUAL ACUITY OF 20/30. ACCORDING TO POST OP AUTOKS, THERE IS +2.50 D OF ASTIGMATISM AT 136. ACCORDING TO POST OP TOPOGRAPHY, THERE IS +2.42 D AT 113 DEGREES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 19308255 ↗InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED INTOLERABLE HALOS. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) LENS MODEL APPROXIMATELY 1 AND HALF MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS REPORTED INTOLERABLE HALOS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Halo
MAUDE report 19011502 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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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