Clareon CNWET3 (UDI 00380652485524)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric · 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 00380652485524), received between Jan 1, 2024 and Jan 1, 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
- Diplopia/Double Vision1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 1, 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, THE PATIENT CAN READ NORMAL SIZE FONTS ON PHONE AT A MINIMUM DISTANCE OF 19-20 - NOT THE BEST. THE PATIENT GOOD WITH MEDIUM DISTANCES LIKE A TV; HOWEVER, WHEN DRIVING AT NIGHT, PATIENT HAD CHALLENGES. AT NIGHT, STOP LIGHTS DO NOT HAVE HALOS, BUT SEEING SORT OF A DUPLICATE IMAGE OFFSET BY 45 DEGREES OF SO, AS GETS CLOSER TO 120 FEET THE TRAFFIC LIGHT PERFECTLY CLEAR. CAR BREAK LIGHTS IN THE DISTANCE LOOK LIKE PERFECT RED DOTS WITH NO HALO OR ANY OTHER PROBLEM AT ALL. DURING THE DAYTIME NO PROBLEM WITH ANYTHING, EXCEPT FOR READING MY MOBILE DEVICE IS FURTHER THAT PATIENT EXPECTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, PATIENT SAW AN OPTOMETRIST WHO DETERMINE THAT HAD EXCELLENT VISION BUT WAS UNABLE TO PROVIDE AN OPINION ON WHY PATIENT SEE DUPLICATE OBJECTS AT NIGHT. THE PATIENT UNDERWENT A YAG PROCEDURE ON THE LEFT EYE, THE OPHTHALMOLOGIST SAID THE RIGHT LENSES WAS CLEAR. AFTERWARDS, PATIENT CAN SEE A SLIGHT VISION IMPROVEMENT BUT STILL SEE A TWO IMAGES SLIGHTLY OFFSET TO EACH OTHER AT A 45 DEGREE ANGLE . SAME FOR STOP LIGHT OR ANY BRIGHT LIGHT AT NIGHT. YET, ALL FREEWAYS SIGNS READ PE
Patient problems: Diplopia/Double Vision
MAUDE report 18423096 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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