Clareon CCWTT3 (UDI 00380652457286)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon PanOptix Toric UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652457286), received between Sep 26, 2023 and Oct 30, 2024 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Contamination with Chemical or Other Material1
- Malposition of Device1
- Material Split, Cut or Torn1
Patient problems
- Blurred Vision3
- Insufficient Information2
- Visual Disturbances2
- Halo1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DISINTEGRATE AFTER BEING INSERTED INTO THE EYE. THE LENS LOADED NORMALLY, WE USED THE CARTRIDGE AND THE LOADER. THE SURGEON REPORTED THIS HAS NEVER HAPPEN TO HIM BEFORE AND USED THE BACK UP LENS WITHOUT DIFFICULTY. THE LENS WAS LOADED AFTER PHACO WHILE THE PROVIDER IS USING THE IA (IRRIGATION AND ASPIRATION). ADDITIONAL INFORMATION WAS RECEIVED, LENS LOADED INTO COMPANY CARTRIDGE WITHOUT DIFFICULTY. IT WAS PLACED IN THE COMPANY LENS LOADER APPROXIMATELY 3-5 MIN PRIOR TO INSERTION. WHEN THE PROVIDER BEGAN INSERTING THE LENS INTO THE CAPSULAR BAG HALF OF THE LENS EXITED THE INSERTER AS EXPECTED INTACT WHILE THE REMAINDER OF THE LENS WHEN ADVANCED BY THE PROVIDER DISINTEGRATED INTO MULTIPLE PIECES. THE LENS WAS THEN REMOVED FROM THE EYE AND THE BACKUP LENS WAS USED.
Patient problems: Insufficient Information
MAUDE report 20570533 ↗InjuryOct 22, 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 HALOS, UNABLE TO DRIVE, REDUCED NEAR VISUAL ACUITY AND POSITIVE DYSPHOTOPSIA. CLINICAL REASON FOR EXPLANT WAS REFRACTIVE ERROR/ DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS MODEL WITH SAME DIOPTER 11 MONTHS 21 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. AS PER SURGEON'S PROGNOSIS GOOD POSTOPERATIVE APPEARANCE. POST IOL EXCHANGE YAG LASER WAS PERFORMED. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT'S ISSUE WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment
MAUDE report 20509323 ↗InjuryOct 4, 2024Malposition of Device; Malposition of Device
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DISTORTED VISION. CLINICAL REASON BEING MENTIONED AS DISLOCATED IOL (INTRAOCULAR LENS). THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE PATIENT DID NOT GET AN IOL (INTRAOCULAR LENS) EXCHANGE AND PROCEDURE WAS COMPLETED BY REPOSITION OF THE LENS.
Patient problems: Blurred Vision
MAUDE report 20376792 ↗InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT BOTHERED BY HALOS AND NOT ABLE TO SEE WELL UP CLOSE NEEDING READERS. THE IOL WAS EXCHANGED FOR ANOTHER MONOFOCAL LENS 11 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE SYMPTOMS WERE RESOLVED AND THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 18168426 ↗MalfunctionSep 26, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN REPORTED THAT THE SURGEON FOUND METAL PARTICLE EMBEDDED IN THE PERIPHERY OF THE IOL WHEN IMPLANTED. LENS WAS EXPLANTED BEFORE THE PATIENT LEFT THE OPERATION ROOM AND SENT FOR ELECTRON MICROSCOPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17815762 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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