Clareon CCWET6 (UDI 00380652456487)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652456487), received between May 13, 2025 and May 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Product Quality Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Product Quality Problem1
Patient problems
- Corneal Edema1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2025Product Quality Problem; Product Quality Problem
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS WAS IN THE EYE, NOTICED THAT THE AXIS MARKS ON THE IOL WERE ABOUT 30 DEGREES COUNTERCLOCKWISE FROM THE HAPTIC BASE. PHYSICIAN MADE THE ASSUMPTION THAT THE TORIC AXIS MARKS WERE CORRECTLY PLACED ON THE OPTIC AND POSITIONED THE LENS WITH THE IOL AXIS MARKS AT 144 DEGREES, LEAVING THE HAPTICS AT AXIS 110 DEGREES. PHYSICIAN INFORMED PATIENT THAT THIS WAS AN UNUSUAL SITUATION THAT NOT ENCOUNTERED BEFORE AND PHYSICIAN MADE THE JUDGEMENT THAT THE AXIS MARKS WERE LIKELY CORRECTLY POSITIONED ON THE IOL, BUT THAT THERE WAS A CHANCE THAT THE AXIS MARKS ARE INCORRECT IN WHICH CASE PATIENT MAY NEED A LENS ROTATION OR POSSIBLY AN IOL EXCHANGE. THERE WAS NO PATIENT HARM. PATIENT HAD MILD CORNEAL EDEMA AT DAY ONE POST OPERATIVE VISIT WITH MILD HYPEROPIC ASTIGMATISM ON AUTOREFRACTION BUT THIS WAS LIKELY TO CHANGE WITH RESOLUTION OF MILD CORNEAL EDEMA. ADDITIONAL INFORMATION RECEIVED STATING THAT ONE-WEEK POST OPERATION PATIENT WAS VERY HAPPY. PHYSICIAN DILATED LEFT EYE AND IOL AXIS MARKS ARE AT 138 DEGREES (TARGETED 144 DEGREES). THEY WILL PROCEED WITH CATARACT SURGERY ON RIGHT EYE NEXT WEEK, ALSO TO USE A T
Patient problems: Corneal Edema; Visual Disturbances
MAUDE report 22015656 ↗
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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