Clareon CCWET3 (UDI 00380652455312)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric UVA · Class 3 · Implant
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00380652455312), received between Nov 4, 2022 and Jun 9, 2026 — classified as 20 injuries, 2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem15
- Device Dislodged or Dislocated2
- Scratched Material2
- Break1
- Crack1
- Failure to Deliver1
- Insufficient Device Problem Information1
Patient problems
- Visual Impairment12
- Blurred Vision9
- Visual Disturbances7
- Insufficient Information3
- Eye Pain1
- Headache1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED SEVERE GLARE AND VISUAL DISTORTIONS. CONSEQUENTLY, THE LENS WAS REMOVED AND REPLACED WITH AN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS SCRATCHED IOL. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE IOL WAS EXCHANGED WITH A NON-COMPANY LENS OF HALF A DIOPTER LESS POWER THAN THE ORIGINAL LENS DURING A SECONDARY PROCEDURE. THE SURGERY INVOLVED PATIENT'S RIGHT EYE. IT IS UNKNOWN WHETHER THE PATIENT¿S SYMPTOMS WERE RESOLVED. THE SURGEON REPORTED THAT THE PROGNOSIS WAS GUARDED. THERE WAS NO FURTHER IMPACT TO THE PATIENT.
Patient problems: Visual Disturbances
MAUDE report 25443953 ↗InjuryMay 8, 2026Break; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, EXPLANTED IOL WITH UNSPECIFIED REASON. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT PATIENT'S VISION WAS NOT CLEAR. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON WAS HAPTIC BROKEN AND LENS NOT IN CORRECT POSITION.
Patient problems: Blurred Vision
MAUDE report 25125391 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING GLARE AND ANISOMETROPIA DUE TO POWER SURPRISE. CLINICAL REASON IS GLARE AND ANISOMETROPIA. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 1 MONTHS 1 WEEK FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 24469976 ↗MalfunctionDec 12, 2025Failure to Deliver; Failure to Deliver
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THE LENS STUCK IN THE SHOOTER.
Patient problems: Insufficient Information
MAUDE report 23789078 ↗InjuryOct 29, 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 VISION WAS NOT CLEAR IN ANY FIELD. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS UNDER CORRECTED ASTIGMATISM/WRONG IOL SELECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23412223 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED POOR QUALITY VISION. THE LENS WAS REMOVED AND REPLACED WITH A NON-COMPANY IOL IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS REDUCED BEST CORRECTED VISUAL ACUITY (BCVA). IN THE SURGEON'S OPINION, THE IOL WAS RESPONSIBLE FOR THE PATIENT'S EVENTS. THE PATIENT'S SYMPTOMS WERE RESOLVED AFTER LENS EXCHANGE, AND THE SURGEON REPORTED A GOOD PROGNOSIS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23288676 ↗InjurySep 11, 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 WAS UNABLE TO SEE ADEQUATELY OUT OF LEFT EYE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 MONTHS 07 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS LEFT EYE WAS NOT CLEAR ESPECIALLY FOR READING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23028226 ↗InjuryAug 26, 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 EXPERIENCED BLURRY VISION. CLINICAL REASON FOR EXPLANT WAS POSITIVE DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR MONOFOCAL MODEL COMPANY LENS 03 MONTHS 28 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 22895870 ↗InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD POSITIVE DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 3 MONTHS AND 6 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 22873891 ↗InjuryJun 10, 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 EXPERIENCED BLURRY VISION AT DISTANCE, MAKING IT HARD TO READ CAPTIONS ON TV, CORRECTION DOES NOT HELP. CLINICAL REASON FOR EXPLANT WAS VISUAL DISCOMFORT. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL LENS 1 MONTH, 2 WEEKS, 4 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 22174895 ↗InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING POOR DISTANCE VISION. CLINICAL REASON IS PATIENT WAS DISSATISFIED WITH LENS. THE IOL WAS EXCHANGED FOR UNKNOWN INTRA OCULAR LENS 1 MONTH 3 WEEKS 1 DAY FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 22013004 ↗InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD MASSIVE SURGICAL MISS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 21272783 ↗MalfunctionNov 14, 2024Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS INSERTED AND REMOVED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20688552 ↗InjurySep 20, 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 BLURRY VISION. CLINICAL REASON FOR EXPLANT WAS REFRACTIVE SURPRISE/ANISEMETROPIA. THE IOL WAS EXCHANGED FOR ANOTHER MODEL COMPANY LENS 1MONTH 4 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 20266119 ↗InjurySep 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 HAD REFRACTIVE LENS MISS. THE IOL WAS EXCHANGED FOR UNSPECIFIED ATIOL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 20137100 ↗InjuryJul 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE HAD DIFFICULTY WITH NIGHT VISION, FELT LIKE HAD BAD ASTIGMATISM OR SOMETHING, SEES MULTIPLE HEADLIGHTS OF ONCOMING CARS. EYES GET SORE WHEN IN FLUORESCENT LIGHTING AND HEADACHE. IOP WAS NORMAL AND RETINA WAS FINE. VISION WAS 20/40 IN RIGHT EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Pain; Headache; Visual Impairment
MAUDE report 19674753 ↗InjuryMay 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS WAS EXPLANTED AT SECONDARY PROCEDURE. THE IOL WAS REPLACED WITH UNSPECIFIED MONOFOCAL LENS APPROXIMATELY TWO MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19339510 ↗InjuryApr 5, 2024Crack; Crack
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON LENS INSERTION THE LENS WAS CRACKED, THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS. THE MAIN WOUND WAS SUTURED AT THE END OF THE SURGERY.
Patient problems: Insufficient Information
MAUDE report 19049384 ↗InjuryJan 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 REPORTED PSEUDOPHAKIA. 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 18501497 ↗InjuryNov 15, 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 POOR VISION. 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 18137912 ↗InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED THAT THE DISTANCE VISION WAS BLURRED AND ALSO EXPERIENCED RESIDUAL REFRACTIVE ERROR. THE LENS WAS REPLACED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 16544320 ↗InjuryNov 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PHYSICIAN REPORTED FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT VISUAL ACUITY 20/50-1 AND J3 AT 14" AND J3 AT 32". REFRACTION AND CURRENT LENS AXIS AT 39 DEGREES, INTENDED AXIS OF 49 DEGREES. ASTIGMATISMFIX.COM STATES TO ROTATE THE IOL TO 102 DEGREES WITH EXPECTED RESIDUAL REFRACTION OF -0.27 -0.71 X 102 DEGREES. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE LENS WAS EXCHANGED WITH A ANOTHER LENS IN A SECONDARY PROCEDURE.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 15730834 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.