Clareon CCWET3 (UDI 00380652455176)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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652455176), received between Oct 11, 2024 and Oct 11, 2024 — classified as 1 injury.
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 Problem1
Patient problems
- Dry Eye(s)1
- Eye Irritation1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT AFTER CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, HE EXPERIENCED POSITIVE DYSPHOTOPSIA. HE ALSO EXPERIENCED FLICKERING LIGHT, SOMETIMES HE COULD SEE THE LENS WITH A BRIGHT SIDE LIGHT AND A DARK ROOM, WORSE INDOORS WITH SIDE LIGHT, NOT AS BAD OUTSIDE IF SUNNY AND PUPILS WERE DILATED. THE VISION WAS WORST INDOORS WITH AMBIENT LIGHT OR A ROOM WITH LOTS OF WINDOWS. CONSUMER ALSO HAD DRY EYES. CONSUMER REPORTED THAT SINCE SURGERIES, IT FELT LIKE HE WAS WEARING HARD CONTACT LENSES THAT NEED TO BE TAKEN OUT FOR RELIEF. HE SQUINTED A LOT, WHICH FELT LIKE IT HELPED WITH THE FLICKERING. THE CONSUMER HAD DISCUSSED THESE CONCERNS WITH HIS EYE CARE PROVIDER, WHO ADVISED TO WAIT A YEAR/OR TAKE DROPS TO DILATE EYES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Dry Eye(s); Eye Irritation; Visual Disturbances
MAUDE report 20428023 ↗
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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