Clareon™ CC60WF (UDI 00380652397018)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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652397018), received between Feb 22, 2025 and Feb 22, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).
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
- Material Split, Cut or Torn1
Patient problems
- Corneal Edema1
- Corneal Endothelial Cell Loss1
- Eye Injury1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
AN ACCOUNT MANAGER REPORTED WITH A DESCRIPTION OF CRACK ON LENS AFTER IMPLANTATION. LENS WAS EXPLANTED IN A INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AS SURGEON ATTEMPTED TO IMPLANT A COMPANY +29.5 IOL USING A COMPANY CARTRIDGE, BUT THE LENS WAS FOUND TO BE FRACTURED NEAR THE OPTIC. AFTER CONSULTING ANOTHER PHYSICIAN, THE LENS WAS REMOVED AND REPLACED WITH ANOTHER COMPANY +29.5 USING A CARTRIDGE (UNCERTAIN IF IT WAS THE SAME ONE). HOWEVER, THE SECOND LENS ALSO SHOWED A FRACTURE NEAR THE OPTIC CENTER. DUE TO IRIS TRAUMA FROM THE FIRST LENS REMOVAL AND NO ADDITIONAL +29.5 IOLS AVAILABLE, THE DECISION WAS MADE TO LEAVE THE FRACTURED LENS IN SITU AND CLOSE THE CASE. ONE WEEK POST-OP, THE PATIENT REPORTED 20/80 VISION, WITH CORNEAL EDEMA LIKELY CONTRIBUTING, POSSIBLY DUE TO ENDOTHELIAL DAMAGE, IRIS TRAUMA, OR THE FRACTURED OPTIC.
Patient problems: Corneal Edema; Corneal Endothelial Cell Loss; Eye Injury; Visual Impairment
MAUDE report 21440701 ↗
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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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