Clareon™ CC60WF (UDI 00380652396783)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
Quick summary
This Alcon Clareon lens is an artificial lens implanted in the eye during cataract surgery. Reports mostly describe lenses found scratched, cracked or with broken supports during loading, so a replacement lens was used, with a few mentions of blurry vision after surgery. There are 24 reports naming its identifier, with no deaths and 7 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00380652396783), received between Jan 9, 2023 and Sep 18, 2026 — classified as 7 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Material Split, Cut or Torn4
- Scratched Material4
- Defective Device2
- Failure to Advance2
- Break1
- Crack1
- Device Contamination with Chemical or Other Material1
Patient problems
- Insufficient Information14
- No Clinical Signs, Symptoms or Conditions4
- Blurred Vision2
- Capsular Bag Tear2
- Capsular Contracture2
- Keratitis2
- Posterior Capsule Opacification2
- Visual Impairment2
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Failure to Advance
A Nurse reported that during the intraocular lens (IOL) implant procedure lens felt sticky and not right when about to implant.Additional information received and confirmed that the lens inserter got stuck when advancing the lens.
Patient problems: Insufficient Information
MAUDE report 50813400 ↗MalfunctionAug 10, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50195032 ↗MalfunctionJan 23, 2026Device Difficult to Setup or Prepare; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED ISSUE WHILE LOADING THE LENS AND WORRIED IT MIGHT BE SCRATCHED. THE PROCEDURE WAS COMPLETED ON SAME DAY USING SAME MODEL AND DIOPTER COMPANY LENS. THERE WERE NO PATIENT CONTACT AND NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED AND NO NEW INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24161813 ↗MalfunctionDec 2, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE HAPTIC OF THE LENS WAS BROKEN. HENCE THIS LENS WAS NOT IMPLANTED AND THE ISSUE WAS FOUND BEFORE BEING PLACED IN A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23690454 ↗InjuryNov 14, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE LENS WAS PARTIALLY INJECTED, AND THE INCISION NEEDED TO BE ENLARGED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM.
Patient problems: Eye Injury
MAUDE report 23555320 ↗InjurySep 10, 2025Adverse 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, THERE WAS AN UNEXPECTED OUTCOME AFTER CATARACT SURGERY IN THE LEFT EYE. THE CONSUMER COULD NOT SEE TO DRIVE BUT COULD SEE TO READ UP CLOSE. THE CONSUMER WAS SEEN BY AN OPTOMETRIST AND WAS TOLD NEARSIGHTED. THE CONSUMER SAW THE EYE CHART WELL THROUGH THE LENSES DURING REFRACTION. THE CONSUMER HAD EXPECTED TO SEE AT DISTANCE. THE CONSUMER WAS SCHEDULED TO SEE THE SURGEON THE FOLLOWING WEEK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23016601 ↗MalfunctionAug 13, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SCRATCH WAS NOTICED ON LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. IT WAS REPORTED THAT THERE WAS NO ADVERSE EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22795939 ↗InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD POSTERIOR CAPSULE OPACIFICATION (PCO), ANTERIOR CHAMBER FLARE, PHIMOSIS AND UNDERWENT YTTRIUM ALUMINUM GARNET (YAG) CAPSULOTOMY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT SURGEON NOTICED CARTRIDGE MATERIAL ADHERES TO POSTERIOR SURFACE OF LENS REQUIRING REMOVAL WITH IRRIGATING THE ANTERIOR CHAMBER OF THE EYE, WHICH WAS SOMETIMES DIFFICULT.
Patient problems: Capsular Contracture; Keratitis; Posterior Capsule Opacification
MAUDE report 22059887 ↗MalfunctionMay 1, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT LENS HAD CRACKS AT THE 6 AND 12. DOCTOR DESCRIBED THEM AS TIGER STRIKES, THE LENS WAS LOADED CORRECTLY. DOCTOR OPTED TO LEAVE THE LENS IN AS THESE DEFECTS WHERE ON THE OUTER EDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21941032 ↗MalfunctionApr 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BROKEN INTO HALF WHEN TRIED TO IMPLANT. OBSERVED CRACKS AND IMPERFECTIONS ON LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21875168 ↗MalfunctionApr 18, 2025Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21863965 ↗MalfunctionApr 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BROKEN IN HALF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21863598 ↗InjuryApr 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED AND STATED THAT SURGEON NOTICED CARTRIDGE MATERIAL ADHERES TO POSTERIOR SURFACE OF LENS REQUIRING REMOVAL WITH IRRIGATING THE ANTERIOR CHAMBER OF THE EYE, WHICH WAS SOMETIMES DIFFICULT.
Patient problems: Capsular Contracture; Keratitis; Posterior Capsule Opacification
MAUDE report 21848088 ↗InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD CAPSULAR TEAR WHICH RESULTED IN THE NEED TO USE A 3 PIECE LENS. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS RECEIVED IT STATES THAT THE PATIENT'S ISSUES RESOLVED AND LENS WAS ABLE TO TAKE OUT SUCCESSFULLY AND USED ANOTHER LENS INSTEAD.
Patient problems: Capsular Bag Tear
MAUDE report 21227791 ↗InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED BLURRY VISION WITH HEADACHES DUE TO DIFFERENCE BETWEEN EYES. CLINICAL REASON BEING MENTIONED AS ANISOMETROPIA. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN NON COMPANY LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Headache; Visual Impairment
MAUDE report 20310313 ↗MalfunctionSep 9, 2024Device Damaged by Another Device; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS GOT PINCHED IN THE CARTRIDGE. THE SURGERY WAS COMPLETED BY REMOVING THE LENS AND REPLACING IT WITH A MONOFOCAL LENS IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20175893 ↗MalfunctionMay 14, 2024Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS JAMMED IN INJECTOR OR INJECTOR PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19308370 ↗MalfunctionApr 16, 2024Inaccurate Delivery; Inaccurate Delivery
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS WAS LOADED UPSIDE DOWN. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS.
Patient problems: Insufficient Information
MAUDE report 19115844 ↗MalfunctionMar 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS SPLIT AFTER INSERTING INTO THE EYE. SUBSEQUENTLY, IT WAS REMOVED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18872873 ↗MalfunctionFeb 2, 2024Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE DEFECTIVE. THE LENS WAS CUT OUT AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18629752 ↗MalfunctionJul 21, 2023Crack; Crack
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER INSERTION, IT WAS DISCOVERED THAT IOL LOOKED CRACKED/SCRATCHED. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17370588 ↗InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
WITH AVAILABLE INFORMATION, THE FILE WAS REVIEWED AND REASSESSED AND IT HAS BEEN DETERMINED THAT THERE WAS NO REPORTED DEFECT OR FAULT WITH A COMPANY PRODUCT.
Patient problems: Capsular Bag Tear
MAUDE report 17207707 ↗MalfunctionJun 22, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 17181543 ↗MalfunctionJan 18, 2023Device Contamination with Chemical or Other Material; Scratched Material; Device Contamination with Chemical or Other Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE EXPERIENCED DEBRIS OR A SCRATCH ON LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16195020 ↗MalfunctionJan 9, 2023Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT A LENS MISFIRED/MALFUNCTION DURING LENS IMPLANTATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16122747 ↗
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.