Clareon CNWET3 (UDI 00380652466493)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652466493), received between Jan 9, 2024 and Jan 30, 2026 — classified as 3 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Break2
- Material Split, Cut or Torn2
- Defective Device1
- Failure to Deliver1
- Scratched Material1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- Blurred Vision2
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT WAS DISSATISFIED WITH DISTANCE VISION, DISTANCE VISUAL ACUITY THROWING PATIENT OFF. PATIENT LIKES NEAR AND INTERMEDIATE VISION. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS PATIENT AIMED FOR -100 BUT STILL DISSATISFIED.
Patient problems: Blurred Vision
MAUDE report 24222743 ↗MalfunctionDec 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAD A FAILURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT, THE LENS WAS CHIPPED.
Patient problems: Insufficient Information
MAUDE report 23829483 ↗MalfunctionNov 4, 2025Break; Failure to Deliver; Break; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS STUCK IN LOADER AND HAPTIC BROKE. THE LENS WAS NOT USED. ADDITIONAL INFORMATION RECEIVED STATING THAT LENS GOT STUCK IN COMPANY CARTRIDGE ON ADVANCEMENT AND THE HAPTIC BROKE. THE SURGERY WAS COMPLETED WITH BACK UP LENS. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23461733 ↗MalfunctionJun 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CRACKED LENS DURING LOADING. THERE WAS A PATIENT CONTACT AND NO PATIENT HARM. LENS WAS EXPLANTED IN INITIAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22305610 ↗MalfunctionJun 6, 2025Break; Break
A NURSE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAPTIC BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE EVENT OCCURRED DURING THE PROCEDURE AND THERE WAS PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 22157517 ↗InjuryJan 10, 2025Adverse 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, LENS WAS EXPLANTED IN SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED DIFFICULTY READING TV CAPTIONS 6 FT, TROUBLE READING ROAD SIGNS, CANNOT DRIVE AT NIGHT. VISUAL ACUITY WAS NOT SHARP. THE CLINICAL REASON WAS REPORTED TO BE GENERAL DYSPHOTOPSIA. THE IOL WAS REPLACED WITH OTHER COMPANY LENS APPROXIMATELY THREE MONTHS AFTER INITIAL PROCEDURE. THERE WAS NOT PATIENT HARM.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 21125155 ↗MalfunctionJun 5, 2024Scratched Material; Scratched Material
HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS SHOWS A SMALL MARK, WHICH WAS NOT CAUSED BY THE INJECTOR FOR ITS IMPLANTATION. NO DAMAGE WAS DONE TO THE PATIENT, AND THE CATARACT REMOVAL AND LENS PLACEMENT WERE COMPLETED WITHOUT FURTHER ISSUES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19466614 ↗MalfunctionApr 18, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE MARKINGS WERE NOT IN THEIR USUAL PLACE ON THE IOL HAPTIC AND OPTIC JUNCTION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19133103 ↗InjuryJan 9, 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 RESIDUAL ASTIGMATISM/MYOPIA AND CLINICAL REASON FOR EXPLANT BEING REFRACTIVE ERROR NOT TOLERATED. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 18473948 ↗
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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