Clareon CCWTT3 (UDI 00380652457309)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon PanOptix Toric UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652457309), received between Jun 20, 2023 and Jan 29, 2025 — classified as 5 injuries.
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 Problem5
Patient problems
- Blurred Vision3
- Visual Disturbances2
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED STATING THAT THE PATIENT EXPERIENCED TEMPORAL CRESCENT-SHAPED NEGATIVE DYSPHOTOPSIA, NOTICED MOST OF THE TIME AND DID NOT IMPROVE WITH ADDITIONAL HEALING. IN THE SURGEON'S OPINION, THE IOL DESIGN (EDGE OF THE IOL) CONTRIBUTED TO THE EVENT. THE LENS WAS EXCHANGED WITH A NON-COMPANY IOL AFTER THE INITIAL IMPLANT PROCEDURE. THERE WAS NO PATIENT HARM. THE PATIENT'S ISSUE WAS RESOLVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR RIGHT EYE.
Patient problems: Visual Disturbances
MAUDE report 21264644 ↗InjuryDec 11, 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 HAD GLARE, REDUCED CONTRAST, FLUCTUATING VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS MECHANICAL COMPLICATION.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 20901507 ↗InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED POOR/BLURRY VISION. CLINICAL REASON MENTIONED AS ARGOS SHOWS NO ASTIGMATISM, BUT PENTACAM SHOWS PATIENT DOES. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE SECONDARY IMPLANT PROCEDURE.
Patient problems: Blurred Vision
MAUDE report 20463463 ↗InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT AN INTRAOCULAR LENS (IOL) EXPLANT DUE TO PSEUDOPHAKIA. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18510526 ↗InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED AFTER SURGERY, IOL WAS EXPLANTED WITH REASON WAS ALL RANGES OF VISION ARE BLURRY. IOL WAS REPLACED WITH A NON COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 17162246 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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