Clareon™ CC60WF (UDI 00380652396776)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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652396776), received between Apr 20, 2023 and Aug 7, 2026 — classified as 3 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (8 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material8
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Device Difficult to Setup or Prepare2
- Material Split, Cut or Torn2
- Product Quality Problem2
- Crack1
- Defective Device1
Patient problems
- Insufficient Information15
- No Clinical Signs, Symptoms or Conditions4
- Blurred Vision2
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Insufficient Device Problem Information
A non-healthcare professional reported that, following the intraocular lens (IOL) implantation procedure, a lens exchange was performed. The initially implanted lens was removed and replaced with a different type of lens. No further information was provided.
Patient problems: Insufficient Information
MAUDE report 50176683 ↗MalfunctionJun 22, 2026Particulates; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING IMPLANTATION, THE SURGEON NOTICED THAT THE LENS WAS DAMAGED. A SMALL PIECE OF PLASTIC, WHICH APPEARED TO BE A MANUFACTURING DEFECT, WAS PRESENT ON THE BOTTOM PART OF THE LENS. THE SURGEON EXTRACTED THE LENS AND REPLACED IT WITH A NEW IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25579070 ↗MalfunctionFeb 11, 2026Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LARGE SCRATCH ON LENS WAS DISCOVERED ONCE THE LENS WAS IMPLANTED INTO THE PATIENT EYE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE LENS WAS IMPLANTED AND REMOVED FROM THE PATIENT EYE IN THE SAME SURGERY. A SIMILAR REPLACEMENT LENS OF SAME MODEL AND DIOPTER WAS IMPLANTED TO COMPLETE THE PROCEDURE ON THE SAME DAY AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24311961 ↗MalfunctionJan 2, 2026Device Difficult to Setup or Prepare; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS NOT USED DUE TO SCRATCHED LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23946500 ↗MalfunctionDec 26, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN DURING LOADING. THEY ALSO STATED THAT THE LENS WAS NOT INJECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23898219 ↗MalfunctionNov 28, 2025Product Quality Problem; Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, TWO LENSES WERE DEFECTIVE, AND STAFF MENTIONED THAT DOCTOR MESSED IT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23671787 ↗MalfunctionJul 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, NOTICED THAT THE LENS WAS FOLDED OR TORN AND NOT ABLE TO BE PLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22393848 ↗MalfunctionJun 6, 2025Device Difficult to Setup or Prepare; Material Twisted/Bent; Device Difficult to Setup or Prepare; Material Twisted/Bent
A NON HEALTHCARE PROFESSIONAL REPORTED THAT LENS DID NOT FOLD INTO INJECTOR CARTRIDGE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT BACK HAPTIC BENT WHEN ADVANCING, LOADING/WOULD NOT LOAD CORRECTLY. PROCEDURE WAS COMPLETED ON THE SAME DAY. LENS WAS NEVER INSERTED INTO THE EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22156006 ↗MalfunctionMay 23, 2025Product Quality Problem; Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DEFECTIVE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22079302 ↗MalfunctionFeb 19, 2025Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING AN DURING AN INTRAOCULAR IMPLANTATION PROCEDURE V SHAPED CRACKS OR MARKS ON THE OPTIC WAS NOTICED. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21409406 ↗MalfunctionJan 3, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SIGNIFICANT SCRATCHES LARGE AND CRACK LIKE. SEASONED TECH WAS IN THE ROOM AND LENSES WERE LOADED JUST BEFORE IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE SIX MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLIANT. THIS REPORT IS 1 OF 6.
Patient problems: Insufficient Information
MAUDE report 21065186 ↗MalfunctionDec 4, 2024Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF SCRATCH ON THE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20842911 ↗InjuryNov 1, 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 WENT FOR THE CHECKUP AND SAID THAT HIS VISION WAS BLURRING OUT EVERY 20 TO 30 SECONDS, ASKED HIM TO KEEP USING THE EYE DROPS EVERYTHING WILL CLEAR UP. PATIENT HAD A SECOND INDEPENDENT EXAM AND THEY SAID IF YOUR VISION WASN'T BLURRING IN AND OUT THAT WOULD HAVE 20/20, PLANNED FOR LENS REPLACEMENT. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.
Patient problems: Blurred Vision
MAUDE report 20585534 ↗InjuryOct 30, 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 WENT FOR THE CHECKUP AND SAID THAT HIS VISION WAS BLURRING OUT EVERY 20 TO 30 SECONDS, IT BECOME WORSE AND ASKED HIM TO KEEP USING THE EYE DROPS EVERYTHING WILL CLEAR UP. PATIENT HAD A SECOND INDEPENDENT EXAM AND THEY SAID IF YOUR VISION WASN'T BLURRING IN AND OUT THAT WOULD HAVE 20/20, PLANNED FOR LENS REPLACEMENT. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.
Patient problems: Blurred Vision
MAUDE report 20569130 ↗MalfunctionJun 12, 2024Break; Scratched Material; Break; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, SCRATCHES ACROSS OPTIC AND PART OF HAPTIC BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19518687 ↗MalfunctionFeb 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF TORN LENS AND WHICH MIGHT BE POSSIBLE CARTRIDGE OR LENS ISSUE.THERE WAS PATIENT CONTACT.THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18684380 ↗MalfunctionAug 7, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN NOTICED THAT THERE WAS A WHITE SPOT IN THE OPTIC. HENCE THE LENS WAS DISCARDED AND ANOTHER LENS WAS IMPLANTED IN THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17469298 ↗MalfunctionApr 27, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT THE LENS ARE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16822287 ↗MalfunctionApr 25, 2023Crack; Crack
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WERE CRACKED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16807021 ↗MalfunctionApr 20, 2023Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON THE LENS WAS NOTED AND IT WAS NOT TOO DISTANT FROM THE TRAILING HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THE LENS REMAINED IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 16774044 ↗
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- 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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