Clareon™ CC60WF (UDI 00380652397001)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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652397001), received between Jul 19, 2022 and Jul 14, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Crack” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Crack2
- Break1
- Defective Component1
- Failure to Unfold or Unwrap1
- Material Deformation1
- Optical Decentration1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2025Material Deformation; Material Deformation
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER INSERTION A DEFECT WAS NOTED IN THE CENTER OF THE LENS, SO DOCTOR OPTED TO REMOVE AND REPLACE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH COMPANY SAME LENS MODEL AND DIOPTER. THERE WAS NO PATIENT HARM. IN THE SURGEON¿S OPINION DEFECT IN THE CARTRIDGE CONTRIBUTED TO EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22495121 ↗MalfunctionFeb 5, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED THAT HAPTIC WAS BROKEN. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE LENS WAS LOADED AND IMPLANTED AND HAD TO BE CUT OUT DUE TO BROKEN HAPTIC. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 21313425 ↗MalfunctionMar 4, 2024Optical Decentration; Optical Decentration
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE LENS WAS NOT CENTERED IN THE EYE. THE LENS WAS EXPLANTED AND PROCEDURE COMPLETED WITH NEW LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18825400 ↗MalfunctionOct 20, 2023Crack; Defective Component; Crack; Defective Component
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL LOADED THROUGH A CARTRIDGE AND THE HAPTIC WAS AMPUTATED, THE OPTIC HAD A CRACK IN THE CENTER OF LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17974513 ↗MalfunctionAug 9, 2022Crack; Crack
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING A INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD MULTIPLE CRACK AFTER IMPLANTATION. ADDITIONAL INFORMATION AHS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15189840 ↗MalfunctionJul 19, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL DID NOT OPEN CORRECTLY ACCORDING TO THE SURGEON. THE SURGEON REPLACED WITH BACK UP LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15051634 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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