Clareon CCWET3 (UDI 00380652455305)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652455305), received between Aug 9, 2022 and Jul 10, 2026 — classified as 8 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Device Dislodged or Dislocated2
- Particulates2
- Scratched Material2
- Break1
- Defective Device1
- Material Twisted/Bent1
Patient problems
- Insufficient Information5
- Blurred Vision4
- Posterior Capsule Opacification2
- Visual Impairment2
- Diplopia/Double Vision1
- No Clinical Signs, Symptoms or Conditions1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Disturbances1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS DEFORMED/ASYMMETRIC AND CAME OUT WEIRD. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25775589 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL HAD REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT HAD BLURRED VISION, DIFFICULTY READING, DIFFICULTY SEEING STREET SIGNS AND ARE MODERATE IN SEVERITY, RIGHT EYE WORSE THAN LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 24762192 ↗MalfunctionNov 11, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON IMPLANTATION A SCRATCH WAS NOTICED ON THE LENS. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23521606 ↗MalfunctionOct 17, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO HAVE BROKEN HAPTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23322556 ↗InjuryMay 23, 2025Particulates; Device Dislodged or Dislocated; Particulates; Device Dislodged or Dislocated
A NURSE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS ROTATED FROM 90 DEGREES TO 80 DEGREES. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE GRADE 2 PCO AT 3 MONTHS, IOL WAS ROTATED AXIS FROM 12 DEGREES TO 30 DEGREES, CONCERNED REGARDING THE LENS MATERIAL VERSES CARTRIDGE MATERIAL CAUSING THE LENS TO BE SLICK AND ROTATE. THE SURGEON NOTICED CARTRIDGE MATERIAL ADHERES TO POSTERIOR SURFACE OF LES REQUIRING REMOVAL WITH IRRIGATION AND ASPIRATION BUT THAT CAN SOMETIMES BE DIFFICULT.
Patient problems: Posterior Capsule Opacification
MAUDE report 22077319 ↗InjuryApr 15, 2025Particulates; Device Dislodged or Dislocated; Particulates; Device Dislodged or Dislocated
A NURSE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS ROTATED FROM 90 DEGREES TO 80 DEGREES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; Posterior Capsule Opacification
MAUDE report 21839907 ↗InjuryDec 3, 2024Adverse 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED BLURRY VISION. THE CLINICAL REASON WAS REPORTED TO BE MECHANICAL COMPLICATION OF IOL. THE IOL WAS REPLACED WITH OTHER COMPANY LENS WITHIN A MONTH AFTER INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision
MAUDE report 20834613 ↗InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT AFTER SURGERY, THE PATIENT HAD EXPERIENCED TASS (TOXIC ANTERIOR SEGMENT SYNDROME). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 20376215 ↗MalfunctionMay 13, 2024Defective Device; Defective Device
A NURSING TECHNICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, A DEFECT IN THE LENS WAS NOTICED. IT WAS EXPLANTED IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19297842 ↗InjuryApr 5, 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 BLURRED VISION. CLINICAL REASON WAS MENTIONED AS LENS EXCHANGE TO HELP WITH DISTANCE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision
MAUDE report 19049006 ↗InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED AN THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED HORRIBLE BLURRY VISION, UNABLE TO SEE CLEARLY AND DISTANCE, DIPLOPIA. CLINICAL REASON WAS MENTIONED AS MAP DOT DYSTROPHY. THE IOL WAS EXCHANGED FOR ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Impairment
MAUDE report 18993033 ↗MalfunctionJul 18, 2023Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17341629 ↗InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISUAL OUTCOME AND REFRACTIVE SURPRISE. HENCE THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT HARM AND NO HOSPITALIZATION REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 15191392 ↗
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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