Clareon CCW0T3 (UDI 00380652431828)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652431828), received between Jan 5, 2024 and Apr 17, 2026 — classified as 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated3
- Defective Device1
- Failure to Advance1
- Failure to Eject1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
- Product Quality Problem1
- Scratched Material1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions3
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2026Device Dislodged or Dislocated
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DISLOCATION OF LENS WAS OCCURRED. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911454 ↗InjuryApr 15, 2026Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A COMPANY MONOFOCAL LENS OF A DIFFERENT MODEL BUT UNKNOWN DIOPTER VALUE IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANTATION WERE A MYOPIC OUTCOME, OVER TREATED ASTIGMATISM AND FLIPPED AXIS. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE IOL EXCHANGE WAS DONE WITH A COMPANY MONOFOCAL LENS OF A DIFFERENT MODEL AND ONE AND HALF DIOPTER LESS POWER.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 24884582 ↗MalfunctionOct 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS WAS IN CARTRIDGE AND CRACK WAS DISCOVERED UPON IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23348791 ↗MalfunctionAug 22, 2025Product Quality Problem; Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22873726 ↗MalfunctionJun 30, 2025Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE HAPTICS HAD POOR TENSION AND WOULD NOT STAY IN PLACE IN THE PATIENT'S EYE. THE LENS WAS EXPLANTED AND REPLACED WITH ALTERNATIVE REPLACEMENT LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22352942 ↗MalfunctionFeb 20, 2025Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE DOCTOR NOTICED SCRATCH ON THE LENS UNDER THE MICROSCOPE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE SURGERY WAS COMPLETED BY REPLACING THE LENS WITH ANOTHER LENS DURING THE SAME SURGERY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21422786 ↗MalfunctionSep 9, 2024Failure to Eject; Failure to Eject
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WAS JAMMED IN THE INJECTOR. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20176275 ↗MalfunctionApr 1, 2024Failure to Advance; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED WITH THE DESCRIPTION OF WOULD NOT ADVANCE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19010462 ↗MalfunctionJan 5, 2024Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DAMAGED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18449828 ↗
Other intraocular lens devices
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- 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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