Clareon™ CC60WF (UDI 00380652396745)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652396745), received between Oct 4, 2022 and May 25, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2026Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE WHILE LOADING, LENS WAS FOUND TO BE SCRATCHED FROM THE MANUFACTURING COMPANY. THE LENS WAS NOT IMPLANTED AND THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25271083 ↗
• MalfunctionApr 20, 2026Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS STUCK UNDER LENS PUSHER WITH PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24927069 ↗
• MalfunctionMar 3, 2026Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONCE THE LENS WAS IMPLANTED INTO THE PATIENT EYE SURGEON DID NOT LIKE HOW LENS LOOKED. THERE WAS A POSSIBLE SCRATCH ON THE LENS, SO THE LENS WAS EXPLANTED AND PLACED A NEW LENS OF SAME DIOPTER AND MODEL AND COMPLETED THE PROCEDURE ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496636 ↗
• MalfunctionAug 7, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BENT OR CRIMPED AND THE PRODUCT WAS UNUSABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22738317 ↗
• MalfunctionJan 6, 2025Defective Component; Defective Component

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC WAS DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE SURGERY WAS COMPLETED USING ANOTHER LENS.

  Patient problems: Insufficient Information

  MAUDE report 21088255 ↗
• InjuryDec 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE ARGOS SHOWS RIGHT EYE WITH 16.0 DIOPTER FOR COMPANY LENS PREDICTED OUTCOME OF -0.42. DOCTOR PERFORMED A SURGERY ON PATIENT (B)(6) 2024 WITH THAT POWER OF IOL. POST-OPERATIVE DAY 1 EVERYTHING LOOKED GREAT BUT CF4 VISION. SENT TO RETINA SAME DAY AND IMAGING WAS NORMAL. ON (B)(6) 2024, DOCTOR WAS ABLE TO REFRACT HIM WITH -8.00 SPHERE TO 20/20. RECOGNIZING THIS WAS ABOUT A 10 DIOPTER DIFFERENCE AT THE IOL PLANE, RE RAN CALCULATIONS FOR A -8.00 POST OPERATIVE GOAL AND THE RECOMMENDED IOL WAS A 26.0 DIOPTER. DOCTOR'S SUSPICION WAS THAT THIS WAS A MISLABELED IOL AND PLANNED TO DO AN IOL EXCHANGE (WITH A 16.0 D IOL) AND ROLL THE CURRENT IOL SO IT CAN BE READ. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21015165 ↗
• InjuryJul 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT REPORTED THAT FAR VISION IS SO BAD, CAN'T SEE ANYTHING. ADDITIONAL INFORMATION WAS RECEIVED AND STATED PATIENT CONTACTED THE SURGEON THREE TIMES, ON SECOND TIME OF APPOINTMENT SURGEON TOLD THERE WAS CORNEAL SWELLING ALSO SURGEON THOUGHT IT WAS "GETTING BETTER." PATIENT ALSO HAD ASTIGMATISM IN THE RIGHT EYE. PATIENT DISTANT VISION IS STILL NOT GOOD, IT IS ALL FUZZY. CANNOT DRIVE CAR OR WATCH TV WITH RIGHT EYE.

  Patient problems: Blurred Vision; Corneal Edema

  MAUDE report 19675210 ↗
• MalfunctionMar 4, 2024Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS NOTED TO BE SCRATCHED. LENS WAS EXPLANTED IN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18826812 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL), THE PATIENT HAD FOREIGN BODY SENSATION AND HAZY BLURRED VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER MULTIFOCAL LENS WITHIN ONE MONTH OF THE INITIAL PROCEDURE. THE CLINICAL REASON WAS EXPLANT WAS REPORTED AS MECHANICAL COMPLICATION OF INTRAOCULAR LENS. THE PATIENT'S SYMPTOMS WERE RESOLVED AFTER REPLACEMENT OF LENS.

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye

  MAUDE report 16092890 ↗
• InjuryOct 4, 2022Crack; Crack

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACK WAS OBSERVED AT JUNCTION OF LEADING HAPTIC AND OPTIC. THE IOL WAS EXPLANTED AND EXCHANGED WITH ANOTHER IOL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS NOTED THAT THE LENS FAILED TO CENTER. FURTHER INSPECTION REVEALED A CRACK IN THE IOL HAPTIC. THE EYE WAS REFILLED WITH OPHTHALMIC VISCOSURGICAL DEVICES (OVD) AND THE FORCEPS AND SCISSORS WERE USED TO CUT AND REMOVE THE DAMAGED IOL. THE BAG WAS REFILLED WITH VISCOELASTIC, AND A NEW IOL WAS INSERTED AND ROTATED INTO POSITION. THE LENS WAS WELL CENTERED. THE REMAINING VISCOELASTIC WAS REMOVED USING THE IRRIGATION/ASPIRATION HANDPIECE. THE ANTERIOR CHAMBER WAS INFLATED WITH BALANCED SALT SOLUTION (BSS), AND THE TEMPORAL WOUND WAS HYDRATED AND SEALED. THERE WAS NO PATIENT HARM, AND THE PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT.

  Patient problems: Eye Injury

  MAUDE report 15538924 ↗