Clareon CCA0T3 (REF CCA0T3.220)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON UVA TORIC ATME · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652440356), received between Dec 19, 2025 and Aug 30, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 Difficult to Setup or Prepare1
- Product Quality Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Visual Impairment
MAUDE report 50514807 ↗MalfunctionJan 7, 2026Product Quality Problem
AN OPHTHALMOLOGIST REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, IT WAS NOTED THAT THE LENS DOTS WERE NOT ALIGNED PRECISELY TO THE HAPTICS. THE LENS WAS ALIGNED ACCORDING TO THE DOTS TO CORRECT ASTIGMATISM. IT WAS NOT EXPLANTED; IT REMAINS IN PATIENT'S EYE. THERE WAS NO PATIENT INJURY. THE SURGEON PLANS TO FOLLOW UP WITH THE PATIENT TO EVALUATE THE POSTOPERATIVE OUTCOME. BASED ON NEW INFORMATION RECEIVED, THE PATIENT¿S POSTOPERATIVE REFRACTION IS +0.50 / -0.50, AND THE PATIENT IS DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23988181 ↗MalfunctionDec 19, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED VIA REPLY CARD THAT THE INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED, BECAUSE THE PRELOADED DEVICE WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23848736 ↗
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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