Clareon CCW0T3 (UDI 00380652431637)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652431637), received between Sep 3, 2024 and Nov 18, 2025 — classified as 1 injury, 1 malfunction.
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 18, 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
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Device Difficult to Setup or Prepare; Product Quality Problem; Device Difficult to Setup or Prepare; Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A COMPANY INJECTOR WAS USED. THE SERIAL NUMBER WAS NOT KNOWN. NO SPECIFIC DETAILS WERE PROVIDED, AND IT WAS UNCLEAR WHAT EXACTLY HAD OCCURRED. IT WAS MOST LIKELY RELATED TO THE LENS OR HOW IT WAS LOADED, BUT THIS COULD NOT BE CONFIRMED. THE REPRESENTATIVE DID NOT BELIEVE IT WAS AN ISSUE WITH THE ACTUAL HANDPIECE ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23579076 ↗InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULD NOT READ SIGNS AFTER 9 FEET AND ANYTHING CLOSER THAN 3 FEET AND FEELS IMBALANCE OF RIGHT EYE. THE IMBALANCE WAS CHALLENGING. THE DOCTOR FEELS THE IMPLANT AND FIT WAS CORRECT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT SURGEON FEELS THERE WAS SOME IMPROVEMENT BUT PATIENT WAS UNABLE TO READ TRAFFIC SIGNS, STREET SIGNS. THE PATIENT FEELS THE CONDITION WAS SAME AND THE IMBALANCE CAUSES DIFFICULTY TO WALK INTO WALLS AND TO CONCENTRATE AND READ. THE CLOSE UP VISION WAS WORSE THAN EXPECTED. THE PATIENT WAS USING READING GLASSES FOR WORK.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 20127236 ↗
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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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