Clareon CCW0T4 (UDI 00380652432962)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 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 00380652432962), received between May 4, 2023 and Nov 10, 2025 — classified as 3 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 Problem3
- Crack1
Patient problems
- Visual Disturbances2
- Visual Impairment2
- Blurred Vision1
- Flashers1
- Halo1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EXPERIENCED POOR VISION. THE IOL HAD BEEN EXCHANGED FOR A MONOFOCAL IOL 1 MONTH, 1 WEEK, AND 5 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 23510233 ↗InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DID NOT ABLE TO OBTAIN A CONSISTENT REFRACTION, HAD A BLINDING AND SOMETIMES PAINFUL GLARE BOTH DAY AND NIGHT. THE PATIENT ALSO EXPERIENCED HALOS BOTH INSIDE AND OUTSIDE AND HAD SEEN CORNEAL SPECIALISTS AND RETINA SPECIALIST WITH NO FINDINGS ON EXAM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment
MAUDE report 20427747 ↗InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED SEVERE GLARE AND ALSO STATES THE CLOUDINESS IS FLUID AND GOES IN AND OUT. THE PATIENT WAS NATURALLY MONOVISION PREVIOUSLY. ADDITIONALLY, THE PATIENT EXPECTED TO HAVE A BETTER VISION TO READ AFTER IMPLANTATION BUT THE PATIENT WAS UNABLE TO READ WITH THIS EYE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PATIENT WAS EXPERIENCING PERIPHERAL SHADOWS TEMPORALLY, OCCASIONAL FLASHES, GHOSTING AND HORRIBLE GLARE IN HER LEFT EYE.
Patient problems: Flashers; Visual Disturbances
MAUDE report 17169237 ↗MalfunctionMay 4, 2023Crack; Crack
ADDITIONAL INFORMATION RECEIVED STATING THE SURGERY WAS DELAYED BY 8 TO 10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16867009 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page