Clareon CCWTT3 (UDI 00380652457279)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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652457279), received between Jul 14, 2022 and Feb 16, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Halo1
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH HALOS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 07 MONTHS 24 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS IOL COMPLICATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: Halo
MAUDE report 24343485 ↗InjuryOct 27, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A MATERIALS MANAGER REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY FOUND SMUDGED LENS AND IT WAS REMOVED BY IRRIGATION AND ASPIRATION. ADDITIONAL INFORMATION WAS RECEIVED STATING THE LENS WAS EXPLANTED.
Patient problems: Insufficient Information
MAUDE report 15678886 ↗InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A BILLING PERSON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION, UNBALANCED, SIGNS OF KERATOCONUS . THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Impairment
MAUDE report 15014795 ↗
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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