Clareon CCWET0 (UDI 00380652405706)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652405706), received between Jun 26, 2023 and Sep 9, 2026 — classified as 10 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Opacification” (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 Problem10
- Material Opacification1
- Scratched Material1
Patient problems
- Blurred Vision10
- Visual Impairment4
- Visual Disturbances3
- Insufficient Information2
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
A non-healthcare professional reported that following an intraocular lens (IOL) implant procedure, the patient reported blurred vision. The IOL was exchanged for non company lens 49 days following the initial implant procedure. Additional information has been received stating that there was no patient harm.
Patient problems: Blurred Vision
MAUDE report 50696616 ↗InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLIRRY VISION. THE LENS HAD BEEN EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS MECHANICAL COMPLICATION.
Patient problems: Blurred Vision
MAUDE report 25580546 ↗InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY AND WONKY VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH NON-COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS POSITIVE DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION WAS RECEIVED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 24344718 ↗InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD BLURRED VISION WITH FLICKER/GLITTERING OF LIGHT/GLARES. THE LENS WAS EXCHANGED FOR AN UNKNOWN MONOFOCAL INTRAOCULAR LENS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON WAS OTHER MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT IN THE SURGEON¿S OPINION THE PRODUCT CONTRIBUTED TO THE EVENT.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 24021697 ↗InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. CLINICAL REASON WAS MENTIONED AS MECHANICAL COMPLICATION OF IOL. THE LENS WAS EXPLANTED AND EXCHANGED WITH MONOFOCAL LENS 4 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LENS WAS EXCHANGED WITH OTHER COMPANY LENS MODEL. THERE WAS NO PATIENT IMPACT.
Patient problems: Blurred Vision
MAUDE report 24021696 ↗InjuryJan 8, 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 AND POSITIVE DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS MODEL 11 MONTHS 28 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 24016709 ↗InjuryOct 25, 2024Adverse 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, THE PATIENT VISION WAS NOT WELL I.E, NOT ABLE TO SEE TV OR STREET SIGNS. CLINICAL REASON BEING MENTIONED AS LENS IMPLANT IS NOT AT THE INTENDED TARGET. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 20535785 ↗InjuryApr 16, 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 DIFFICULTY IN READING BOOKS AND NEEDS READERS. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS HYPEROPIC SURPRISE. THE LENS WAS PLANNED TO BE EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 19114674 ↗InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 18629074 ↗MalfunctionJan 9, 2024Material Opacification; Material Opacification
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS APPEARED TO BE CLOUDY/DEFECTIVE/BUBBLE. HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 18481138 ↗MalfunctionNov 24, 2023Scratched Material; Scratched Material
ADDITIONAL INFORMATION RECEIVED AND STATED THAT NO MALFUNCTION WITH THE LENS.
Patient problems: Insufficient Information
MAUDE report 18204132 ↗InjuryJun 26, 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 HAD BLURRED VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MYOPIC SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 17199799 ↗
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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