Clareon™ CC60WF (UDI 00380652396950)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652396950), received between Mar 13, 2023 and Aug 8, 2023 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Crack2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information3
- Visual Disturbances1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2023Break; Crack; Break; Crack
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE HAPTIC OF THE LENS CRACKED, AND MULTIPLE CRACKS WERE FOUND IN THE OPTIC OF THE LENS AFTER INSERTION, REQUIRING CUTTING AND REMOVAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17481118 ↗MalfunctionJun 30, 2023Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS FOUND TO BE BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17238048 ↗InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE SHE EXPERIENCED EXTREME GLARE WITH THE LENS. SHE WAS UNABLE TO DRIVE AT NIGHT DUE TO DEBILITATING GLARE. IT WAS LIKE A WALL OF WHITE.
Patient problems: Visual Disturbances
MAUDE report 16672023 ↗MalfunctionMar 13, 2023Crack; Crack
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PARTIAL FRACTURE OR CRACK THROUGH CENTRAL OPTIC. HIGH EFFORT DURING INITIAL INJECTION, BUT THEN SMOOTHED OUT. IT WAS REPORTED THAT UNEVENTFUL LENS LOADING. THE LENS EXPLANTED AND REPLACED IMMEDIATELY DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16528012 ↗
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- 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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