Clareon CNWET3 (UDI 00380652466356)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652466356), received between Nov 15, 2024 and Feb 2, 2026 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 Problem4
- Device Difficult to Setup or Prepare1
- Scratched Material1
Patient problems
- Blurred Vision2
- Diplopia/Double Vision1
- Insufficient Information1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 30 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS INTOLERANCE DUE TO GLAUCOMA ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 24234243 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DOUBLE VISION. CLINICAL REASON BEING MENTIONED AS DIPLOPIA. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Diplopia/Double Vision
MAUDE report 23462157 ↗MalfunctionNov 3, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A SCRATCH DUE TO LOADING ERROR AND HAD BEEN REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23452750 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED PRESBYOPIA WHICH WAS NOT CORRECTED AT ALL AND THE PATIENT CANNOT READ WITHOUT ADDITIONAL GLASSES. ASTIGMATISM WAS NOT CORRECTED AND THE VISION HAS WORSENED, PREVIOUSLY PATIENT COULD WORK ON THE COMPUTER WITHOUT GLASSES BUT NOW GLASSES ARE NEEDED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, ON (B)(6) 2024 IOL WAS INSERTED INTO THE RIGHT EYE. THE NEXT DAY PATIENT NOTICED THAT RIGHT EYE WAS NOT SEEING WELL BOTH FAR AND NEAR, THE ASTIGMATISM WAS NOT ELIMINATED AND ALL OBJECTS STILL HAD A SECOND CONTOUR. PATIENT COULD NOT READ TEXT FROM A SMARTPHONE OR A BOOK AT A DISTANCE OF 40-45 CM. ON (B)(6) 2024, A FOLLOW UP EXAMINATION WAS CONDUCTED WHERE PATIENT REPORTED ALL THE SHORTCOMINGS AND WERE NOT ENTERED INTO THE MEDICAL RECORD. ON (B)(6) 2024 THE NEXT EXAMINATION WAS CONDUCTED, AND DURING THE TIME THAT HAD PASSED SINCE THE FIRST EXAMINATION, THERE WERE NO CHANGES IN THE COMPLAINTS ABOUT THE RIGHT EYE. DURING THE EXAMINATION, IT WAS RECORDED THAT VISUAL ACUITY WAS 0.6 CYLINDRICAL-1.0 AXIS10 = 0.9 FOR THE RIGHT EYE. ADDITIONAL INFORMATION WAS RECEIVED, DOCTOR SAID THAT TH
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 21968307 ↗InjuryNov 15, 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 SAW DISTORTION, THINGS WERE STRETCHED. THE IOL WAS EXCHANGED FOR UNSPECIFIED (ATIOL) ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS POST (LASER-ASSISTED IN SITU KERATOMILEUSIS) LASIK UNPREDICTABLE ASTIGMATISM WANTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 20693484 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page