Clareon CCWTT4 (UDI 00380652457811)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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652457811), received between Apr 18, 2023 and Jan 7, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Crack” (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 Problem2
- Crack1
Patient problems
- Blurred Vision2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2025Adverse 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 EXPERIENCED WITH GLARE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 08 MONTHS 21 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS COULD NOT SEE AT DISTANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 21091004 ↗InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS BOTHERED BY NEAR VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 08 MONTHS 06 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions; Visual Impairment
MAUDE report 19104358 ↗MalfunctionApr 18, 2023Crack; Crack
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE THE SURGEON NOTICED CRACKS IN LENS NEAR THE HAPTICS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT TECH RECEIVED THE LENS IT LOOKED OK AND LOADED PROPERLY. THE SURGEON PLACED IT IN THE EYE AND NOTICED THE CUTS AT THE TOP. HE THEN TOOK THE LENS OUT. THE SCHEDULED PROCESSES WAS COMPLETED THE SAME DAY. THERE WAS PATIENT CONTACT NOTED.
Patient problems: Insufficient Information
MAUDE report 16762128 ↗
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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