Clareon CCWTT3 (UDI 00380652457255)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon PanOptix Toric UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652457255), received between Dec 6, 2023 and Feb 3, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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 Problem2
- Defective Component1
- Device Dislodged or Dislocated1
- Failure to Advance1
- Scratched Material1
Patient problems
- Blurred Vision2
- Visual Impairment2
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REASON VISION WAS STILL BLURRY AND CLINICAL REASON WAS OFF TARGET. THE IOL WAS EXCHANGED FOR REPLACEMENT ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL 01 MONTH 26 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING PATIENT COMPLAINED OF BLURRINESS, MANIFEST REFRACTION SHOWS TORIC IOL OFF AXIS. AS PER THE SURGEON OPINION THE PRODUCT HAD CAUSE OR CONTRIBUTE TO THE EVENT WITH NO PATIENT HARM.
Patient problems: Blurred Vision
MAUDE report 21300846 ↗InjurySep 9, 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 STATED LENS DID NOT HELP VISION (CLOUD IN VISION). THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS SIGNIFICANT DIFFICULTY ADJUSTING TO PANOPTIX LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 20168483 ↗MalfunctionMar 28, 2024Defective Component; Failure to Advance; Scratched Material; Defective Component; Failure to Advance; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT, DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC BECAME STUCK AND WOULD NOT RELEASE FROM THE LENS, RESULTING IN SCRATCHING OF THE LENS IN THE PROCESS, AND LENS WAS REMOVED DURING INITIAL PROCEDURE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18992935 ↗InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD DIFFICULTY SEEING AT DISTANCE. THE PATIENT NEVER FELT LIKE THE VISION WAS IN FOCUS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER TORIC LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 18272989 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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