Clareon™ CC60WF (UDI 00380652396882)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00380652396882), received between Jun 2, 2022 and Jun 12, 2026 — classified as 6 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Product Quality Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, LENS HAD NOTCHES ON THE BACK OF THEM. THERE ARE THREE MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS 3 OF 3. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482834 ↗
• MalfunctionJun 5, 2026Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, NOTCHES IN BACK OF LENS WAS OBSERVED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25407632 ↗
• MalfunctionJun 2, 2026Scratched Material

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION IN PATIENT'S RIGHT EYE, A SCRATCH WAS OBSERVED ON THE POSTERIOR SIDE OF THE IOL AFTER IT WAS IMPLANTED. THE LENS WAS NOT REMOVED FROM THE EYE, IT REMAINS IMPLANTED. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM. ACCORDING TO THE SURGEON, SOMETHING PHYSICALLY SCRATCHED THE POSTERIOR SIDE OF THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361624 ↗
• MalfunctionApr 24, 2026Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A DEFECT WAS NOTICED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24982232 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SHE HAD VERY BRIGHT STARBURSTS AT NIGHT, SO BAD THAT SHE DID NOT FEEL SAFE TO DRIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Visual Disturbances

  MAUDE report 24830059 ↗
• MalfunctionMar 30, 2026Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE HAPTIC WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT HAPTIC GOT STUCK IN THE CARTRIDGE DURING LOADING THE LENS. THERE WAS NO PATIENT CONTACT AND SURGERY COMPLETED SAME DAY WITH REPLACEMENT LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714971 ↗
• MalfunctionMar 18, 2026Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED WITH THE DESCRIPTION OF CRACKED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24626088 ↗
• MalfunctionFeb 16, 2026Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CRACKED LENS. LENS WAS REMOVED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24345372 ↗
• MalfunctionJan 21, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC BROKE WHEN INSERTING INTO LENS CAPSULE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24129245 ↗
• MalfunctionDec 29, 2025Scratched Material; Scratched Material

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906024 ↗
• MalfunctionDec 26, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON IMPLANTATION, THE SURGEON OBSERVED A CENTRAL DEFECT ON THE IOL. THE SURGEON FELT THE DEFECT WAS ON THE IOL AND NOT DUE TO HANDLING OR FOLDING. THE IOL WAS CUT AND REMOVED, AND A SAME-COMPANY, SAME-DIOPTER REPLACEMENT LENS WAS IMPLANTED DURING THE INITIAL PROCEDURE WITHOUT ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901034 ↗
• MalfunctionDec 24, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH FOUND ON LENS AFTER IMPLANTED. THE INCISION WAS NOT ENLARGED, AND THE LENS WAS EXPLANTED AND REPLACED WITH SAME COMPANY SAME DIOPTER REPLACEMENT LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887508 ↗
• MalfunctionDec 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL DID NOT COME OUT SMOOTHLY AND ON INSPECTION IT WAS FOUND TO BE CRACKED IN THREE PLACES ALONG THE EDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PROCEDURE COMPLETED ON THE SAME DAY. LENS REMAIN IMPLANTED. BECAUSE OPTIC WAS PRESERVED AND PATIENT WAS BECOMING SLIGHTLY UNCOMFORTABLE, THE IOL WAS CENTERED ON VISUAL AXIS. THERE WAS NO PATIENT HARM. SURGEON¿S PROGNOSIS WAS FOUND TO BE, ¿PCIOL IN GOOD POSITION OS, OBSERVE. LIMITED VISION DUE TO GEOGRAPHIC ATROPHY AND IOL AIM WAS -2.50 OU.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777036 ↗
• MalfunctionDec 8, 2025Break; Break

  A MATERIALS MANAGER REPORTED THAT THE LEADING HAPTIC WAS SNAPPED IN HALF - UPON INSERTING THE LENS, THE SURGEON NOTICED THAT THE LEADING HAPTIC WAS IN 2 PIECES. THEREFORE, THE LENS WAS NOT IMPLANTED. THE SURGERY WAS COMPLETED BY REMOVING THE LENS AND THE PIECE OF HAPTIC AND REPLACING IT WITH A NEW IDENTICAL LENS IN THE SAME PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23736932 ↗
• MalfunctionNov 14, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SCRATCH ON LENS. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555642 ↗
• MalfunctionSep 10, 2025Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH OR MARK ON OPTIC AFTER IMPLANTATION. THE LENS WAS EXPLANTED AND REPLACED WITH DIFFERENT LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY INJURY TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016000 ↗
• MalfunctionSep 3, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED KINKED HAPTIC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22951636 ↗
• MalfunctionAug 21, 2025Product Quality Problem; Product Quality Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO ISSUE WITH THE INTRAOCULAR LENS (IOL).

  Patient problems: Insufficient Information

  MAUDE report 22862079 ↗
• MalfunctionJul 11, 2025Product Quality Problem; Product Quality Problem

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, STATING LENS HAD DEFECT IN CENTER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22484567 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLAZE OVER VISION, HALOS, GLARE AND DOUBLE VISION. THE PATIENT WAS NOT ABLE TO DRIVE AND THE LENS WAS EXPLANTED AND EXCHANGED WITH ANOTHER COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT HAD MULTIPLE FOLLOW-UPS WITH NEURO OPHTHALMOLOGY AND MANY EYE DOCTORS FOR THE BLURRY VISION. SHE INITIALLY BLAMED THE LENS BUT LENS EXCHANGE WAS UNSUCCESSFUL AT RESOLVING THE SYMPTOMS.

  Patient problems: Diplopia/Double Vision; Visual Disturbances

  MAUDE report 22396935 ↗
• MalfunctionJul 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOLDED OR TORN AND NOT ABLE TO BE PLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22393980 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT SINCE FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLACK ARCS IN VISION. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS MODEL 3 MONTHS 7 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. IN THE SURGEON OPINION THE PRODUCT HAD CAUSED OR CONTRIBUTED TO EVENT. THE PATIENT ISSUE WAS RESOLVED WITH DILATION. IN SURGEON'S PROGNOSIS GOOD POST OPERATIVE APPEARANCE DENIES ARCS WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 22211852 ↗
• MalfunctionMay 29, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS HAD A BROKEN HAPTIC. IT WAS INSERTED BEFORE NOTICING THE DEFECT. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED LENS WAS LOADED AND INSERTED INTO PATIENT'S EYE. SURGEON NOTICED BACK HAPTIC WAS TORN BUT NOT COMPLETELY RIPPED OFF. LENS WAS REMOVED USING MST INSTRUMENTS. AN UNSPECIFIED NEW LENS WAS LOADED AND DELIVERED WITHOUT COMPLICATIONS. IOL WAS COMPROMISED PRIOR TO INSERTION AND WAS NOT SEEN UNTIL IN EYE UNDER MICROSCOPE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105502 ↗
• MalfunctionApr 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY THE LENS WAS NOT IMPLANTED AS A PIECE OF CAME OFF IN THE EYE AND THE PIECE AND LENS WAS REMOVED DURING AN INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857586 ↗
• MalfunctionMar 17, 2025Failure to Deliver; Failure to Deliver

  A FACILITY REPRESENTATIVE REPORTED THAT DURING THE DELIVERY OF INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS UNABLE TO INSERT AS THE LENS KEPT GETTING STUCK IN CARTRIDGE AND DID NOT ADVANCE FROM DELIVERY SYSTEM. WHEN TRYING TO RETRACT THE LENS CAME BACK WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 21623213 ↗