Clareon CCWET3 (UDI 00380652455299)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652455299), received between Mar 20, 2023 and Jan 2, 2026 — classified as 12 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (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 Problem11
- Appropriate Device Problem Term/Code Not Available1
- Malposition of Device1
- Scratched Material1
Patient problems
- Visual Impairment7
- Blurred Vision6
- Insufficient Information3
- Visual Disturbances3
- Eye Pain1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED REFRACTIVE MYOPIA AND CYLINDER. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONALLY THE PATIENT HAD YAG (YTTRIUM ALUMINUM GARNET) LASER SURGERY. PATIENT ISSUES WAS RESOLVED AND IN THE SURGEON PROGNOSIS THE PATIENT CONDITION WAS GOOD. THERE WAS NO FURTHER IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 23941827 ↗InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23051768 ↗InjuryAug 8, 2025Adverse 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, PATIENT UNABLE TO SEE ANYTHING UP CLOSE. THE LENS WAS EXCHANGED WITH NON-COMPANY LENS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT IS +0.40 D MYOPIC MISS. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT¿S ISSUE RESOLVED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 22750722 ↗InjuryMay 19, 2025Adverse 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'S VISION IMPROVED FROM 20/50 TO 20/20, BUT THERE WAS A HALO/STARBURST EFFECT BOTH DAY AND NIGHT. THE SURGEON STATED THAT THE CURRENT COMPANY LENS DID NOT CAUSE THAT ISSUE, YET THE REPORTER HAD BEEN EXPERIENCING IT FOR 3 MONTHS. THE CONSUMER WAS AFRAID TO HAVE THE SECOND EYE FIXED, AS DRIVING AT NIGHT WOULD BE AWFUL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT HAD LASIK SURGERY SEVERAL YEARS AGO AND NOTED HALOS AFTER THAT, BUT THEY RESOLVED WITH TIME. IT WAS MENTIONED BY CONSUMER THAT THE SURGEON ALREADY PERFORMED A YAG (YTTRIUM ALUMINUM GARNET) FOR A WRINKLE/CREASE. THE PATIENT MENTIONED HE JUST ORDERED THE YELLOW SUNGLASSES AND WILL LET KNOW IF THEY WORK ONCE THEY ARRIVE.
Patient problems: Visual Disturbances
MAUDE report 22044864 ↗InjuryFeb 6, 2025Adverse 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 REASON WAS BOTHERSOME DYSPHOTOPSIA AND CLINICAL REASON WAS DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL LENS, 02 MONTHS 09 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING AS PER SURGEON OPINION THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: Visual Disturbances
MAUDE report 21323621 ↗InjuryOct 4, 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 WAS DIFFICULTY TO FOCUS AND NIGHT DRIVING. THE IOL WAS EXCHANGED FOR UNSPECIFIED ATIOL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS INTOLERANT, VERY SYMPTOMATIC. THERE WAS NO PATIENT HARM.
Patient problems: Visual Impairment
MAUDE report 20376788 ↗MalfunctionSep 3, 2024Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING SURGERY, THEY NOTICED A SCRATCH ON LENS PERIPHERY TO CENTRAL BUTTON AFTER IMPLANTATION. LENS WAS LEFT IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 20129358 ↗InjuryJun 12, 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 COULD NOT SEE WELL ENOUGH TO DRIVE, EYES GOT TIRED. THE PATIENT HAD MYOPIC SURPRISE. THE LENS EXPLANTATION HAS BEEN PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Eye Pain; Visual Impairment
MAUDE report 19519478 ↗InjuryMay 1, 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 POOR VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 11 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM.
Patient problems: Visual Impairment
MAUDE report 19220396 ↗InjuryMar 4, 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 BLURRY VISION/HAZY/GLARE AND CLINICAL REASON FOR EXPLANT BEING MECHANICAL COMPLICATION OF IOL . THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 18827749 ↗InjuryOct 3, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT SATISFIED. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. NEW INFORMATION HAS BEEN RECEIVED STATING PATIENT ISSUES HAS BEEN RESOLVED.
Patient problems: Insufficient Information
MAUDE report 17859062 ↗InjurySep 20, 2023Adverse 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 BLURRY VISION. CLINICAL REASON BEING REFRACTIVE ERROR. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 17780427 ↗InjurySep 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO SEE WELL/ TOLERATE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 17675673 ↗MalfunctionMar 20, 2023Malposition of Device; Malposition of Device
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS ROTATED AND HAD TO BE REPLACED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16572638 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page