Clareon™ CC60WF (UDI 00380652396936)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380652396936), received between Mar 21, 2023 and Sep 18, 2026 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Scratched Material

  A non-health care professional reported that during the intraocular lens (IOL) implantation surgery, a scratch was noticed on the lens optic.Additional information was received stating that, the scratch was not observed prior to loading, and it was unknown if it occurred prior to handling, during loading, or during injection. The lens was removed and replaced during the same procedure and the surgery was completed on the same day. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50815169 ↗
• MalfunctionMay 25, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAPTIC WAS BROKEN, NOTICED AFTER LENS WAS IN EYE ALREADY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25270852 ↗
• MalfunctionNov 21, 2025Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, WHEN THE LENS WAS IMPLANTED, A SCRATCH WAS OBSERVED. THE LENS WAS CUT AND EXPLANTED. THE SURGERY WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23617947 ↗
• MalfunctionAug 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON HEALTHCARE PROFESSIONAL REPORTED STATING THAT, AFTER LENS WAS IMPLANTED, LENS APPEARED TO BE CUT DOWN THE MIDDLE. THERE WAS PATIENT CONTACT. THE PROCEDURE COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22873572 ↗
• MalfunctionAug 21, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE GETTING READY TO LOAD THE IOL INTO THE CARTRIDGE, THE SCRUB TECH NOTICED THAT ONE OF THE HAPTICS LOOKED 'FUNKY'. THERE WAS NO PATIENT CONTACT AND PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860954 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT A CONSUMER CALLED TO SEE WHAT TYPE OF LENS WAS IMPLANTED IN HER EYE. SHE STATED SINCE SURGERY SHE WAS HAVING A HARDER TIME TO SEE AT NEAR, CERTAIN CLOSE ITEMS WERE BLURRED, ALMOST DOUBLE. AT NIGHT SHE WAS SEEING HALOS AROUND CAR LIGHTS. SHE SAID HER DOCTOR TOLD HER IT WAS A REFRACTIVE ERROR AND PROVIDED A GLASSES. SHE WAS GOING TO SCHEDULE A SECOND OPINION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT SHE HAD SPOKEN TO SURGEON ABOUT WANTING INTERMEDIATE VISION FROM HER CATARACT SURGERY. HER NEAR VISION WAS WORSE AFTER SURGERY. HAD SURGERY MANY YEARS AGO IN RIGHT EYE DUE TO DM. WAS NOT HAPPY THAT SHE COULD NOT SEE AT NEAR WITHOUT HAVING GLASSES.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Dry Eye(s); Visual Disturbances; Visual Impairment

  MAUDE report 22813740 ↗
• MalfunctionFeb 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS CRACKED. SURGEON FEELS CARTRIDGE HAD SOME ISSUE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 3 OF 4 FILES.

  Patient problems: Insufficient Information

  MAUDE report 21433415 ↗
• MalfunctionFeb 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS CRACKED. SURGEON FEELS CARTRIDGE HAD SOME ISSUE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 2 OF 4 FILES.

  Patient problems: Insufficient Information

  MAUDE report 21432809 ↗
• MalfunctionJul 2, 2024Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAD A SCRATCH NOTICED AFTER IMPLANTATION. THE TECHNICIAN WHO WAS IN CHARGE OF ASSEMBLING THE LENS INDICATES THAT SHE DID NOT NOTICE IF THE LENS HAD A SCRATCH WHEN SHE LOOKED AT IT OR WHEN SHE OPENED AND MOUNTED IT. SURGEON DID NOT REMOVE THE LENS AND REPLACE IT, LEFT THE SAME LENS ON THE PATIENT AND FINISHED THE SURGERY. ADDITIONAL INFORMATION WAS RECEIVED, THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653841 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF BROKEN CAPSULE UPON INSERTION OF IOL. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING NO PATIENT HARM.

  Patient problems: Capsular Bag Tear

  MAUDE report 19328892 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD TROUBLE ADJUSTING TO LENS AND WAS UNHAPPY WITH THE VISION. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER LENS FOLLOWING THE INITIAL PROCEDURE.ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18130001 ↗
• InjuryAug 21, 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) IMPLANTATION, THE PATIENT'S VISION WAS HORRIBLE. THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS STATED AS, "PATIENT HEALED HYPEROPIC FROM THE TARGET". ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT'S RIGHT EYE WAS IMPACTED AND A NON-COMPANY LENS WAS USED AS REPLACEMENT LENS.

  Patient problems: Blurred Vision

  MAUDE report 17583521 ↗
• MalfunctionJul 20, 2023Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GOT STUCK INSIDE THE CARTRIDGE WHEN THE SURGEON WAS ATTEMPTING TO INSERT INTO THE PATIENT. ATTEMPTED SEVERAL TIME TRYING TO GET IT OUT OF THE CARTRIDGE, THE TEAM FELT THAT THE INTEGRITY OF THE LENS WAS COMPROMISED, THEREFORE IT WAS DISCARDED PROPERLY. THE PROCEDURE WAS COMPLETED BY USING NEW LENS AND CARTRIDGE. THE PATIENT WAS NOT HARMED, SURGERY WAS COMPLETED AS PLANNED. THERE WAS PATIENT CONTACT.ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360561 ↗
• InjuryJul 11, 2023Malposition of Device; Malposition of Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED SEVERE GLARE. SHE STATED THAT SHE WAS HAVING CLOUDINESS WHICH IS FLUID AND GOES IN/OUT. THE PATIENT PREVIOUSLY HAD MONOVISION NATURALLY AND THE IMPLANT WAS DONE FOR HER TO READ BETTER BUT AFTER THE LENS IMPLANTATION ALSO, SHE CANNOT READ WITH HER EYES. SHE HAS TO GET CLOSER TO THE SCREEN TO READ. THE DOCTOR STATED THAT, LENS WAS NOT IN GOOD POSITION AND THE GLARE IS HORRIBLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 17297543 ↗
• MalfunctionMar 21, 2023Crack; Crack

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD CRACK IN THE PERIPHERY. THE SURGEON DECIDED TO LEAVE THE LENS IN THE EYE BECAUSE IT WAS OUTSIDE OF THE OPTIC CENTER. THERE WERE NO SAFETY CONCERNS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16582946 ↗