Clareon™ CC60WF (UDI 00380652396875)Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00380652396875), received between Jun 20, 2022 and Sep 15, 2026 — classified as 6 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (24 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Material Twisted/Bent

  A facility representative reported that during an intraocular lens (IOL) implant procedure, defective haptics. The procedure was completed on the same day with another lens.Additional information was requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50768231 ↗
• MalfunctionAug 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209440 ↗
• InjuryAug 7, 2026Particulates

  A nurse reported that, following a cataract surgery with intraocular lens (IOL) implantation, a foreign body was observed in the iris during a postoperative follow-up appointment. The products used during the procedure, were the ophthalmic system, viscoelastic, and IOL. There was no inflammation or other clinical concerns reported. However, the patient experienced "funky" vision. As a result, the patient underwent an additional surgery approximately one month later to remove the foreign body. There was no patient impact reported.Additional information received later confirmed that the foreign body was removed from the iris.

  Patient problems: Eye Irritation

  MAUDE report 50169198 ↗
• MalfunctionJul 27, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50033561 ↗
• MalfunctionJul 16, 2026Material Twisted/Bent

  Patient problems: Insufficient Information

  MAUDE report 25840167 ↗
• MalfunctionMay 29, 2026Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A CENTRAL OPTIC SCRATCH WAS OBSERVED ON THE LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REMOVING THE ORIGINAL LENS AND REPLACING IT WITH THE COMPANY LENS. THE INITIAL DESCRIPTION INDICATES THAT THE SURGERY WAS COMPLETED WITHOUT ISSUE. 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 25333145 ↗
• MalfunctionMay 27, 2026Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE AT THE TIME OF DELIVERY, THE CENTER OPTIC WAS SCRATCHED. THE IOL WAS SUBSEQUENTLY REMOVED AND REPLACED WITH ANOTHER LENS DURING THE INITIAL IMPLANTATION PROCEDURE, WITHOUT ANY ISSUE TO THE PATIENT AND 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 25300561 ↗
• MalfunctionMay 25, 2026Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A SCRATCH ON THE LENS. THE LENS WAS EXPLANTED AND REPLACED WITH SAME MODEL SAME DIOPTER SAME COMPANY REPLACEMENT LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM. 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 25270847 ↗
• MalfunctionApr 13, 2026Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE WHEN THE LENS WAS INSERTED IN THE PATIENT'S LEFT EYE, IT WAS NOTED THAT THE OPTIC WAS TORN. THE LENS WAS CUT AND REMOVED AND REPLACED WITH SAME MODEL AND DIOPTER COMPANY LENS IN AN INITIAL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 24858669 ↗
• MalfunctionApr 10, 2026Device Damaged Prior to Use; Material Split, Cut or Torn

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT. THE ISSUE WITH COMPLAINT PRODUCT NOTICED BEFORE THE CASE PRELOADING. THE ORIGINALLY SCHEDULED PROCEDURE WAS COMPLETED ON THE SAME DAY.

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

  MAUDE report 24841931 ↗
• MalfunctionFeb 19, 2026Product Quality Problem

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS OBSERVED TO BE DEFECTIVE UPON IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THE LENS REMAINED IMPLANTED IN THE EYE.

  Patient problems: Insufficient Information

  MAUDE report 24388181 ↗
• MalfunctionFeb 5, 2026Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION WAS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 24269451 ↗
• MalfunctionJan 30, 2026Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE SURGEON NOTED A CENTRAL DEFECT ON THE IOL AFTER IT WAS PLACED IN THE PATIENT¿S EYE. DUE TO PATIENT'S ANATOMY, THE SURGEON ELECTED TO LEAVE IOL IN EYE.

  Patient problems: Insufficient Information

  MAUDE report 24219295 ↗
• MalfunctionJan 21, 2026Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON IMPLANTATION, SURGEON NOTICED THAT THE LENS WAS CRACKED AND HAD TO EXPLANT LENS AND INSERT A REPLACEMENT DURING SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING IN THE SURGEON¿S OPINION, PRODUCT CAUSED OR CONTRIBUTED TO THE PRODUCT MALFUNCTION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129239 ↗
• MalfunctionJan 9, 2026Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON OBSERVED TWO DIGS/MARKS ON THE ANTERIOR SURFACE OF THE IOL AND THE LENS WAS SLIGHTLY OFF VISUAL AXIS. THE LENS REMAINED IN THE PATIENT EYE, THERE WERE NO ISSUES REPORTED POST-OPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019074 ↗
• MalfunctionJan 2, 2026Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS FOUND TO HAVE A SCRATCHED AND A REFLECTIVE IMPERFECTION IN THE CENTER OF THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23942440 ↗
• MalfunctionDec 25, 2025Material Deformation; Material Deformation

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE THE SURGEON INJECTED THE IOL. ONCE IN THE EYE THE SURGEON NOTICED IT WAS DAMAGED. IOL EXPLANTED AND REPLACED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23892075 ↗
• MalfunctionNov 13, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED A MANUFACTURING ISSUE WITH THE INTRAOCULAR LENS (IOL), DESCRIBING IT AS STREAK ON THE IOL. THE LENS WAS IMPLANTED IN THE PATIENT EYE. THE EVENT OCCURRED DURING IOL IMPLANTATION PROCEDURE. ACCORDING TO THE NEW INFORMATION, THE OBSERVED STREAKS WERE, IN FACT, SCRATCHES. THE DOCTOR FOUND NO ISSUES WHEN HE OBSERVED THE LENS UNDER THE MICROSCOPE. THE LENS WAS LOADED IN THE CARTRIDGE AND IMPLANTED. HOWEVER, ONCE PLACED IN THE EYE, THE DOCTOR IMMEDIATELY NOTED A SCRATCH ON THE LENS IN THE FIELD OF VISION. THE DOCTOR ATTRIBUTED THE OBSERVED SCRATCH TO A POTENTIAL MANUFACTURING ERROR. THE ORIGINALLY SCHEDULED PROCEDURE WAS COMPLETED ON THE SAME DAY; THE LENS REMAINS IMPLANTED. THERE WAS NO PATIENT HARM, THE DOCTOR REPORTED NO ISSUES WITH THE FIELD OF VISION AFTER THE PATIENT'S POST-OP VISIT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23540404 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REASON AS IOL CAME TOO STRONG AND CLINICAL REASON FOR EXPLANT BEING BLURRY VISION IOL CAME TOO STRONG. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23356036 ↗
• MalfunctionSep 2, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE THE LENS WAS CRACKED AND THE HAPTIC WAS BROKEN. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STARTED THAT THE LENS WAS INSERTED AND REMOVED DURING THE INITIAL PROCEDURE AND REPLACED WITH THE COMPANY LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936245 ↗
• MalfunctionAug 28, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS TORN OFF WHILE LOADING THE LENS. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH CONFIRMED CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ALONG WITH A PHOTOGRAPH, STATING THAT THE LENS WAS IMMEDIATELY REMOVED ONCE THE SURGEON NOTICED THE MISSING HAPTIC, AND A NEW IOL WAS PLACED IN THE CAPSULAR BAG WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919879 ↗
• InjuryAug 20, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION (IOL) SURGERY, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS UNSPECIFIED ISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22853133 ↗
• MalfunctionJul 11, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE HAPTIC BROKE OFF, AND UPON REMOVING IT GOT STUCK. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 22479421 ↗
• MalfunctionJun 30, 2025Failure to Deliver; Failure to Deliver

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WOULD NOT SLIDE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22358606 ↗
• MalfunctionMay 20, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS INTACT BEFORE INSERTING INTO CARTRIDGE, BROKEN HAPTIC NOTICED AFTER LENS IMPLANTATION. LENS WAS REMOVED AND NEW LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM. THE SURGEON PROGNOSIS IS NORMAL OUTCOME AND PATIENT IS RESPONDING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055420 ↗