Clareon™ CC60WF (UDI 00380652396769)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
- 16
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380652396769), received between Jun 13, 2022 and Jan 16, 2026 — classified as 2 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (8 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 Material8
- Failure to Deliver3
- Material Split, Cut or Torn2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Crack1
Patient problems
- Insufficient Information9
- No Clinical Signs, Symptoms or Conditions7
- Inflammation1
- Swelling/ Edema1
- Visual Disturbances1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2026Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS BECAME JAMMED IN THE INJECTOR, INJECTOR PROBLEM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24091895 ↗MalfunctionNov 14, 2025Failure to Deliver; Failure to Deliver
ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 23555651 ↗MalfunctionAug 8, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS MISSING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22750416 ↗MalfunctionMay 12, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE LENS STUCK IN DELIVERY SYSTEM OR CARTRIDGE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH UNSPECIFIED LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 22002701 ↗MalfunctionFeb 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED THAT DURING AN INTRAOCULAR IMPLANTATION PROCEDURE THE LENS WAS IMPLANTED AND WAS OBSERVED TO HAVE CRACKS ALONG THE OUTER DIAMETER OF THE OPTIC AND WAS NOT EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21410800 ↗MalfunctionDec 5, 2024Scratched Material; Scratched Material
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING INSERTION, THEY HAD NOTICED THAT THE LENS WAS SCRATCHED AND IT HAD PATIENT CONTACT. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20858357 ↗MalfunctionNov 27, 2024Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCHED LENS. THE LENS WAS EXPLANTED IN INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20799597 ↗MalfunctionJul 29, 2024Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED. THERE WAS PATIENT CONTACT.THE PROCEDURE WAS COMPLETED THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED STATING LENS WAS EXPLANTED IN INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19849745 ↗InjuryApr 16, 2024Scratched Material; Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A SCRATCH IN MIDDLE OF THE LENS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTH FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM AND PATIENT ISSUES WAS RESOLVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19116776 ↗MalfunctionSep 27, 2023Scratched Material; Scratched Material
AN INVENTORY MANAGEMENT SPECIALIST REPORTED THAT WHEN PUTTING THE INTRAOCULAR LENS (IOL) IN THE DOCTOR NOTICED A SCRATCH ON LENS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER COMPANY LENS IN AN INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. IN THE SURGEON'S OPINION, IT IS UNKNOWN IF THE IOL WAS DEFECTIVE, IT COULD BE LOADING ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17823528 ↗MalfunctionJun 19, 2023Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED SCRATCH ON LENS, LENS IMPLANTED AND REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17152751 ↗InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED INFLAMMATION / SWELLING; TREATED WITH STEROIDS, VISON ISSUES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Inflammation; Swelling/ Edema; Visual Disturbances
MAUDE report 17116176 ↗MalfunctionMay 29, 2023Crack; Crack
A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS INSERTED ON UNFOLDING SURGEON NOTICED CRACK IN LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17017224 ↗MalfunctionMay 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT HAPTIC WAS BROKEN AND THE PATIENT CONTACT WAS NOTED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, UPON INJECTING THE IOL INTO THE EYE THE SURGEON NOTICE THAT ONE OF THE OPTICS WAS TORE ALMOST IN HALF OFF THE LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AS INITIAL PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16972503 ↗MalfunctionMar 21, 2023Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SCRATCH WAS NOTED ON BOTH SIDE OF LENS. THERE WAS A PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT, ONCE THE IOL HAD BEEN INTRODUCED INTO THE PATIENT'S EYE, THE SURGEON IMMEDIATELY NOTICED SCRATCHES ON BOTH SIDES OF THE IOL THAT WERE NOT ACCEPTABLE FOR THE PATIENT TO ACHIEVE OPTIMAL VISUAL OUTCOME POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 16585200 ↗MalfunctionJun 13, 2022Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON LENS WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE SCRATCH ON LENS WAS DURING THE INSERTION PROCESS. THERE WAS PATIENT CONTACT WITH THE PRODUCT BUT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14673419 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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