Clareon™ CC60WF (UDI 00380652396691)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652396691), received between Jun 10, 2022 and Aug 20, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (5 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50350161 ↗
• MalfunctionJun 2, 2026Scratched Material

  A PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS OBSERVED ON THE POSTERIOR SIDE OF THE LENS AFTER IMPLANTED. THE LENS WAS NOT REMOVED AND REMAINED IMPLANTED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. ACCORDING TO THE SURGEON, SOMETHING PHYSICALLY SCRATCHED THE POSTERIOR SIDE OF THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361625 ↗
• MalfunctionMay 29, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent

  A NURSE REPORTED A LOADING ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS/HAPTIC STUCK IN CARTRIDGE. THERE WAS NO PATIENT CONTACT AS IT WAS NOTED DURING LOADING. PROCEDURE WAS COMPLETED ON THE SAME DAY. IN THE SURGEONS OPINION, LOADING ERROR CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333388 ↗
• MalfunctionJan 9, 2026Break

  A NURSE REPORTED THAT DURING SURGERY, HAPTIC BROKE OFF WHILE FOLDING THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24017361 ↗
• InjuryDec 26, 2025Optical Decentration; Device Dislodged or Dislocated; Optical Decentration; Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRY VISION. THE LENS WAS EXCHANGED FOR MONOFOCAL LENS MODEL 28 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS LENS OFF CENTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23897392 ↗
• MalfunctionDec 5, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAD METALLIC LOOK TO IT AFTER IT WAS IMPLANTED INTO THE EYE. THE IOL WAS REMOVED AND PLACED A NEW LENS WHICH APPEARED FINE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT IOL HAD METALLIC ARTIFACT OR SILVER BODY AND ALSO STATED THAT IT COULD HAVE BEEN SCRATCH OR DEFECT IN THE LENS THAT SHIMMERED. SURGEON STATED THAT LENS WAS EXPLANTED AND IMPLANTED AN NEW LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725898 ↗
• MalfunctionApr 28, 2025Material Twisted/Bent; Material Twisted/Bent

  A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC SHEARED AND TWISTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 21918257 ↗
• MalfunctionFeb 18, 2025Scratched Material; Scratched Material

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON THE LENS WAS NOTICED. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND IT WAS COMPLETED ON THAT DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21400032 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED TROUBLE WITH CONTRAST VISION OUTDOORS AND INDOORS. EVERYTHING WAS DARK AFTER SURGERY AND WAS UNABLE TO DRIVE AT NIGHT. THE PATIENT ALSO HAD YAG LASER. THE PATIENT SEEN SURGEON MANY TIMES WHO TOLD THAT NO PROBLEM WITH VISION AND IT WOULD IMPROVE, NOTHING WAS FOUND ON EXAM. THE SURGEON TOLD PATIENT MIGHT HAVE DRY AGE RELATED MACULAR DEGENERATION (AMD) AND PRESCRIBED GLASSES WHICH WERE NOT HELPFUL. THE PATIENT HAD 2ND OPINION AND WAS TOLD MIGHT HAVE WET AMD .THE MD SAID NO NEED FOR SHOTS AND ITS DES NOT AMD. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT VISION WAS NOT IMPROVED .THE WAVELENGTH OF BLACK CONTRAST IS AFFECTED. PATIENT HAD A CONTRAST SENSITIVITY TEST DONE WHICH WAS INCONCLUSIVE. THE PATIENT FEELS THE LENS WAS BLOCKING THE LIGHT GETTING IN TO THE EYE. THE LENS WAS ATTENUATING THE RANGE OF COLORS GETTING INTO EYES. THE LIGHT WAS NOT MAKING IT DIRECTLY INTO THE EYES. THE PATIENT WAS TESTED WITH COLOR PLATES AND COULD NOT SEE ANY OF THEM. THE CONSUMER WAS ON FIBEROPTICS. THERE ARE 2 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS O

  Patient problems: Blurred Vision; Dry Eye(s); Visual Impairment

  MAUDE report 17570878 ↗
• MalfunctionFeb 24, 2023Crack; Crack

  A NURSE MANAGER REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD TO BE CUT OUT DUE TO CRACKS ON EDGE OF LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16436180 ↗
• MalfunctionJul 12, 2022Ejection Problem; Ejection Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS FLIPPED IN PATIENT'S EYE AND THE SURGEON REPLACED THE LENS AND COMPLETED THE SURGERY DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14987846 ↗
• MalfunctionJun 10, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOTED TO BE SCRATCHED AFTER INSERTION. ADDITIONAL INFORMATION WAS RECEIVED THAT, THE MARKS WERE ON THE EDGE AND NOT IN THE VISUAL AXIS AND THE LENS WAS INSERTED IN THE LEFT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652959 ↗