Clareon CCWET4 (UDI 00380652455718)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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652455718), received between Jan 24, 2024 and May 21, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Product Quality Problem1
- Scratched Material1
Patient problems
- Visual Impairment3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2025Product Quality Problem; Product Quality Problem
¿A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. THE SURGEON NOTICED THAT THE TORIC LENS WAS DEFECTIVE, WITH THE TORIC ALIGNMENT MARKS NOT ALIGNED WITH THE HAPTIC CENTER. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SYMPTOMS WERE CONTINUED. THERE WAS A PLANNED EXPLANT AND NO PATIENT HARM.
Patient problems: Visual Impairment
MAUDE report 22061666 ↗InjuryMar 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT IN THE SURGEON OPINION THE EVENT WAS NOT PRODUCT RELATED BUT ROTATIONAL INSTABILITY. THERE WAS NO PATIENT HARM AND SYMPTOMS WERE RESOLVED.
Patient problems: Visual Impairment
MAUDE report 21662666 ↗MalfunctionNov 6, 2024Scratched Material; Scratched Material
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY HAVE EXPLANTED THE LENS DUE TO IT WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN RECEIVED IT STATES THAT WHEN LOADING LENS WAS SCRATCHED. LENS WAS IMPLANTED THEN EXPLANTED AFTER DOCTOR SAW THE SCRATCH AND REPLACED WITH ANOTHER LENS. PROCEDURE COMPLETED THE SAME DAY. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20621512 ↗InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED REFRACTIVE ERROR. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS REFRACTIVE ERROR.
Patient problems: Visual Impairment
MAUDE report 18570219 ↗
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 13, 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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