Clareon™ CC60WF (UDI 00380652396684)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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652396684), received between Nov 4, 2022 and Jun 30, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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.
Most reported problems
Device problems
- Defective Device2
- Scratched Material2
Patient problems
- Insufficient Information4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2023Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT LENS WAS DEFECTIVE, IT WAS NOT USED, WASTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17242385 ↗MalfunctionJan 18, 2023Defective Device; Defective Device
ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS FURTHER CLARIFIED THAT THERE WAS NO REPORTED DEFECT OR FAULT WITH A COMPANY PRODUCT. THE LENS WAS OPENED AND NOT USED. THE SURGERY WAS COMPLETED WITH A NEW LENS.
Patient problems: Insufficient Information
MAUDE report 16195876 ↗MalfunctionDec 9, 2022Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REQUESTED TO REPLACE THE LENS IN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT HE LENS WAS FOUND TO BE SCRATCHED AFTER INSERTION, THERE FOR LENS WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 15950406 ↗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 15726253 ↗
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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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