Clareon™ CC60WF (UDI 00380652396721)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380652396721), received between Apr 24, 2023 and Apr 10, 2026 — classified as 3 injuries, 14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Material Twisted/Bent

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT THE SURGERY COMPLETED SAME DAY WITH REPLACEMENT LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839755 ↗
• MalfunctionJan 30, 2026Break

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE CARTRIDGE BROKE WHEN INSERTED IN THE EYE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE HAPTIC WAS BROKEN WHEN INSERTED INTO THE CARTRIDGE DURING LOADING AND THERE WAS PATIENT CONTACT.

  Patient problems: Insufficient Information

  MAUDE report 24221163 ↗
• MalfunctionJan 22, 2026Material Deformation

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A CENTRAL DEFECT WAS OBSERVED ON THE IOL UPON IMPLANTATION. THE SURGEON ELECTED TO REMOVE THE IOL AND REPLACE IT WITH A LENS FROM THE SAME MANUFACTURER WITH A DIFFERENT DIOPTER; HOWEVER, A DEFECT WAS ALSO OBSERVED ON THE REPLACEMENT LENS. A SMALL DEFECT WAS NOTED ON THE OUTER OPTIC OF THE IOL, AND THE LENS REMAINED IN THE EYE. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Insufficient Information

  MAUDE report 24144024 ↗
• MalfunctionJan 2, 2026Material Twisted/Bent

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SURGERY WAS COMPLETED ON THE SAME DAY WITH UNSPECIFIED LENS. HAPTIC NOT ATTACHED WAS NOTICED UPON OPENING.

  Patient problems: Insufficient Information

  MAUDE report 23942497 ↗
• MalfunctionDec 23, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE THE SCRATCH WAS FOUND ON BOTTOM OF THE LENS AFTER IMPLANTED. THE LENS WAS REMOVED AND REPLACED WITH COMPANY BACKUP LENS DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876567 ↗
• MalfunctionOct 30, 2025Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED TROUBLE DURING LOADING THE INTRAOCULAR LENS (IOL); IOL GOT SCRATCHED WHILE LOADING. THE INCIDENT OCCURRED DURING IOL IMPLANTATION PROCEDURE. IT WAS FURTHER NOTED THAT THE INJECTOR MIGHT HAVE CAUSED THE SCRATCH ON THE LENS. THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED WITH A BACKUP LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423144 ↗
• MalfunctionOct 16, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAPTIC TORN OR BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED TRAILING HAPTIC 90% SEVERED AT OPTIC-HAPTIC JUNCTION WITH PATIENT CONTACT. THERE WAS NO PATIENT HARM. THE PROCEDURE WAS COMPLETED SAME DAY WITH UNSPECIFIED LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310254 ↗
• MalfunctionJul 25, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED BEFORE IMPLANTING THE LENS. THERE WAS NO PATIENT CONTACT TO THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609013 ↗
• MalfunctionMay 20, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTICS WAS BENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22055967 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS () IMPLANT PROCEDURE THE PATIENT EXPERIENCED POSTERIOR CAPSULE OPACIFICATION (PCO), ANTERIOR CHAMBER FLARE, PHIMOSIS AND UNDERGONE FOR YAG CAPSULOTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, DEVELOPED GRADE 1 POSTERIOR CAPSULE OPACIFICATION (PCO) AT 1 MONTH THAT CONTINUED TO WORSEN. HAVE NOTICED CARTRIDGE MATERIAL ADHERES TO POSTERIOR SURFACE OF LENS REQUIRING REMOVAL WITH IRRIGATION AND ASPIRATION THAT CAN SOMETIMES BE DIFFICULT. PCO, FLOATERS, WITH ANTERIOR CHAMBER FIBROSIS AND EARLY CONTRACTION, VITREOUS SYNERESIS, DENSE OPAQUE ANTERIOR VITREOUS FLOATERS WERE OBSERVED.

  Patient problems: Capsular Contracture; Keratitis; Posterior Capsule Opacification

  MAUDE report 22037245 ↗
• MalfunctionApr 22, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAPTIC BROKEN/TORN/MISSING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE HAPTIC WAS BROKEN AND THE ISSUE WAS NOTICED DURING LOADING/PRIMING/RELOADING AND DID NOT HAVE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881999 ↗
• InjuryApr 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT, DEVELOPED GRADE 1 POSTERIOR CAPSULE OPACIFICATION (PCO) AT 1 MONTH THAT CONTINUED TO WORSEN. HAVE NOTICED CARTRIDGE MATERIAL ADHERES TO POSTERIOR SURFACE OF LENS REQUIRING REMOVAL WITH IRRIGATION AND ASPIRATION THAT CAN SOMETIMES BE DIFFICULT. PCO, FLOATERS, WITH ANTERIOR CHAMBER FIBROSIS AND EARLY CONTRACTION, VITREOUS SYNERESIS, DENSE OPAQUE ANTERIOR VITREOUS FLOATERS WERE OBSERVED.

  Patient problems: Capsular Contracture; Keratitis; Posterior Capsule Opacification

  MAUDE report 21816661 ↗
• MalfunctionFeb 25, 2025Dent in Material; Dent in Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY NOTICED THAT EDGES OF THE IMPLANT APPEARED SHARP AND THERE WAS CONCERN THAT IT WOULD POP THE BAG. SUBSEQUENTLY THE LENS WAS CUT OUT AND REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THE SCHEDULED SURGERY WAS COMPLETED THE SAME DAY. NO APPARENT IMPACT TO THE PATIENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458143 ↗
• MalfunctionJan 6, 2025Scratched Material; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCHED LENS FROM A COMPANY CARTRIDGE WAS IMPLANTED IN PATIENT'S EYE. THE SURGEON CHOSE TO LEAVE THE LENS IMPLANTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081110 ↗
• 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 17570880 ↗
• MalfunctionJul 6, 2023Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INSERTED INTO THE EYE IN NORMAL FASHION BUT ONCE UNROLLED WAS DETERMINED TO HAVE DEFECTS AROUND THE PERIPHERY OF THE OPTICAL ZONE. SMALL CRACKS OR SCRATCHES AT RANDOM INTERVALS IN MULTIPLE PLACES AROUND THE LENS WERE NOTICED. THE IOL WAS REMOVED IN PIECES FROM THE EYE IN THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM AND THE IOL WAS EXCHANGED WITH OTHER LENS OF SAME MODEL AND DIOPTER DURING INITIAL IMPLANT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17268657 ↗
• MalfunctionApr 24, 2023Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT A DEFECTIVE LENS DURING INTRAOCULAR LENS (IOL) IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16793969 ↗