Clareon™ CC60WF (UDI 00380652396714)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon™ Aspheric UV Absorbing IOL - STERILE UV-Absorbing Hydrophobic Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652396714), received between Nov 4, 2022 and Apr 30, 2026 — classified as 3 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (3 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
- Scratched Material3
- Adverse Event Without Identified Device or Use Problem2
- Defective Device2
- Crack1
- Failure to Deliver1
Patient problems
- Insufficient Information5
- Blurred Vision3
- Visual Disturbances2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Excessive Tear Production1
- Eye Injury1
- Eye Pain1
- Halo1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO HAVE A SCUFF AFTER IT WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE IOL WAS EXPLANTED AND REPLACED. THE SURGEON ALSO STATED THAT THE LENS WAS SCUFFED POSSIBLY BY THE CARTRIDGE. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25043954 ↗InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRED VISION. THE LENS WAS EXCHANGED FOR ANOTHER UNSPECIFIED LENS MODEL. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT EXPERIENCED BLURRED VISION WITH GLARES AND HALOS. IN THE SURGEON¿S OPINION, THE PRODUCT CONTRIBUTE TO THE EVENT THERE WAS NO FURTHER IMPACT TO THE PATIENT.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 24049992 ↗MalfunctionNov 19, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS STUCK IN THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23592567 ↗InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT SPECIFICALLY HAS TROUBLE WITH DISTANCE VISION AS WELL AS HALOS WITH NIGHT DRIVING.
Patient problems: Blurred Vision; Halo; Visual Impairment
MAUDE report 18826814 ↗MalfunctionFeb 29, 2024Crack; Crack
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS CRACKED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18805806 ↗MalfunctionNov 23, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DAMAGED INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18199217 ↗InjuryMar 7, 2023Defective Device; Defective Device
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED FROM THE INITIAL REPORTER WHO STATED THAT LEFT EYE WAS STILL HAVING ISSUES OF CLOUDINESS. THERE WAS A HAZE ON THE LEFT EYE TOWARD THE LEFT SIDE OF THE EYE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Excessive Tear Production; Eye Injury; Eye Pain; Headache; Swelling/ Edema; Visual Disturbances
MAUDE report 16494145 ↗MalfunctionDec 14, 2022Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) LENS WAS DEPLOYED AND THEN NOTICED TO BE SCRATCHED SO IT HAD TO BE REMOVED. REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15976194 ↗MalfunctionNov 4, 2022Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS IDENTIFIED AS SCRATCHED AFTER PLACEMENT. THE PROCEDURE WAS COMPLETED. THE PRODUCT WAS IN CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15725523 ↗
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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