Clareon CCW0T5 (UDI 00380652434034)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652434034), received between Aug 20, 2024 and Mar 2, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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
- Device Dislodged or Dislocated2
- Material Deformation1
Patient problems
- Insufficient Information3
- Eye Irritation1
- Loss of Vision1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Material Deformation
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS WASTED BECAUSE OF DEFORMITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24485090 ↗InjuryNov 18, 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 WAS UNABLE TO SEE THE DASHBOARD IN THEIR CAR. THE CLINICAL REASON MENTIONED WAS THAT THE PATIENT HAD BEEN MORE MYOPIC THAN THE COMPANY BIOMETER HAD CALCULATED. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) DURING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE PATIENT HAD BEEN TARGETED FOR MONOVISION AT -2.50 OS. HE REPORTED THAT HE COULD NOT SEE THE DASHBOARD IN THE CAR. HIS VISION HAD ONLY BEEN CLEAR A FOOT IN FRONT OF HIS FACE. THERE WAS NO FURTHER IMPACT TO THE PATIENT.
Patient problems: Visual Impairment
MAUDE report 23583439 ↗MalfunctionMay 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TORIC MONOFOCAL ROTATED 2 TIMES UPON REMOVAL OF IRRIGATION AND ASPIRATION (I/A) TIP FROM EYE 170 DEGREES -> 5 DEGREES. STAYED ON 3RD ATTEMPT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING AS PER SURGEON OPINION, THE PRODUCT CAUSE OR CONTRIBUTE TO THE EVENT AND CONCERNED REGARDING LENS MATERIAL VERSES CARTRIDGE MATERIAL CAUSING THE LENS TO BE SLICK AND ROTATE. POSTOP-OPERATIVE MEDICATION INCLUDED OPHTHALMIC DROPS FOUR TIMES A DAY (QID).
Patient problems: Insufficient Information
MAUDE report 22025952 ↗MalfunctionApr 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TORIC MONOFOCAL ROTATED 2 TIMES UPON REMOVAL OF IRRIGATION AND ASPIRATION (I/A) TIP FROM EYE 170 DEGREES -> 5 DEGREES. STAYED ON 3RD ATTEMPT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21843307 ↗InjuryAug 20, 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 COULD NOT SEE AND FELT UNCOMFORTABLE. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Irritation; Loss of Vision; Visual Disturbances
MAUDE report 20008305 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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