Clareon CNWET0 (UDI 00380652405348)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652405348), received between Mar 13, 2024 and Feb 27, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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. 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
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Damaged by Another Device1
- Failure to Deliver1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT ADVANCE FULLY OUT OF THE CARTRIDGE. PATIENT CONTACT WAS MADE. ANOTHER UNSPECIFIED LENS WAS USED, AND THERE WERE NO ISSUES FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468986 ↗MalfunctionOct 15, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONCE IMPLANTED IT WAS FOUND IN THE CAPSULAR BAG THAT THE HAPTIC WAS CRACKED. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND UNSPECIFIED LENS WAS SUCCESSFULLY IMPLANTED WITHOUT COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23300066 ↗MalfunctionApr 4, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH WAS NOTED ON LENS UPON INSERTION. LENS WAS EXPLANTED IN INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACK UP LENS WITH THE SAME DIOPTER AND SERIES.
Patient problems: Insufficient Information
MAUDE report 21774116 ↗MalfunctionMar 7, 2025Product Quality Problem; Scratched Material; Product Quality Problem; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS EXTRACTED AND NOT USED AS IT WAS DAMAGED. ADDITIONAL INFORMATION STATED THAT LENS WAS FOUND TO HAVE A LARGE DEFECT INTO THE CENTER OF THE OPTIC. THE DEFECT IS AWAY FROM WHERE THE PLUNGER COMES INTO CONTACT WITH THE LENS. THE LENS HAD TO BE EXPLANTED DURING INITIAL PROCEDURE AND BACK UP LENS USED.
Patient problems: Insufficient Information
MAUDE report 21548056 ↗MalfunctionSep 9, 2024Device Damaged by Another Device; Device Damaged by Another Device
AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS BROKE IN THE IMPLANTATION CARTRIDGE WHILE INJECTING INTO THE INJECTOR. THERE WAS NO PATIENT HARM AND PATIENT WAS FEELING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20176530 ↗InjuryMar 13, 2024Adverse 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,LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT REASON WRONG IOL POWER/TORICITY. CLINICAL REASON FOR EXPLANT REPORTED TO BE RESIDUAL REFRACTIVE ERROR/POOR VISION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 18895776 ↗
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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