Clareon™ CC60WF (UDI 00380652396707)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652396707), received between Jun 22, 2023 and Sep 16, 2026 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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. 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 Material4
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Difficult to Setup or Prepare1
- Inaccurate Delivery1
- Material Deformation1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information4
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Inaccurate Delivery
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the IOL was loaded and inserted into OT's eye, however the lens did not inserted properly. The lens was explanted during initial procedure. The procedure was completed on same day. There was no patient harm.Required minimum dataset provided, no further information will be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790440 ↗MalfunctionMay 15, 2026Device Difficult to Setup or Prepare; Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO BE BENT AND WOULD NOT LOAD.
Patient problems: Insufficient Information
MAUDE report 25183918 ↗MalfunctionJan 27, 2026Break
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT TECH RECOGNIZED THE HAPTIC WAS MISSING BEFORE STARTING TO FOLD THE LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189980 ↗MalfunctionDec 12, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A SCRATCH ON THE LENS, DEFECT TOWARDS THE OUTSIDE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789511 ↗MalfunctionDec 12, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A SCRATCH ON THE LENS, DEFECT TOWARDS THE OUTSIDE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789509 ↗MalfunctionJul 23, 2025Scratched Material; Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS JAMMED IN CARTRIDGE AND THE LENS WAS PLACED IN EYE AND IT WAS NOTICED THAT THERE WAS A LITTLE MARK IN THE MIDDLE OF THE IOL AND NEW IOL WAS REQUESTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22576257 ↗InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION THE SURGEON NOTICED SHE NEEDED TO DO A VITRECTOMY AND THERE WAS NO PROOF OF THE LENS CAUSING THIS VITRECTOMY HOWEVER THE SURGEON HAS NEVER SEEN A SITUATION WHERE THIS WOULD HAPPEN AFTER IMPLANTATION AND HAD REQUESTED TO SUBMIT TO MEDICAL SAFETY TO ENSURE NOTHING WAS WRONG WITH THE LENS AND THE LENS WAS EXPLANTED IN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18901691 ↗MalfunctionJan 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE INTRAOCULAR LENS WAS TORN. TH PROCEDURE WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS AS INSERTED AND REMOVED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18454877 ↗MalfunctionJun 22, 2023Scratched Material; Scratched Material
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS FOUND TO BE SCRATCHED. HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME POWER IN THE SAME PROCEDURE. THERE WAS PATIENT CONTACT AND THE PROCEDURE WAS COMPLETE ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17180127 ↗
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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