Clareon CCWET3 (UDI 00380652455329)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652455329), received between Nov 7, 2022 and Aug 27, 2026 — classified as 14 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  A non health care professional reported that following surgery, the patient experienced blurry vision, double vision. The IOL was replaced with an monofocal IOL. As a result, the intraocular lens (IOL) was replaced with unspecified monofocal lens 1 month, 5 days, after the initial implant procedure.Additional information has been requested but is not available at the time of this report.

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 50472631 ↗
• InjuryJul 15, 2025Adverse 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 COULD NOT ADJUST WITH COMPANY LENS AND HAD VISION BLURRY. CLINICAL REASON FOR EXPLANT INCLUDED PATIENT WAS NOT SATISFIED WITH VISUAL OUTCOME. THE IOL WAS EXCHANGED FOR MONOFOCAL NONCOMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22506214 ↗
• InjuryMay 6, 2025Adverse 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 (IOL) IMPLANT PROCEDURE, THE IOL HAS BEEN EXPLANTED IN A SECONDARY PROCEDURE WITH UNKNOWN ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED.

  Patient problems: Blurred Vision; Insufficient Information; Posterior Capsule Opacification; Visual Impairment

  MAUDE report 21971402 ↗
• MalfunctionApr 23, 2025Optical Decentration; Optical Decentration

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR IMPLANT PROCEDURE, THE LENS CENTRATION WAS POOR WITHIN CAPSULAR BAG. THE LENS WAS PLANNED FOR EXPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21888435 ↗
• InjuryApr 22, 2025Adverse 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 BLURRY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 2 MONTHS AND 4 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REFRACTIVE MISS WITH SURGICAL PROCEDURE LASIK (LASER ASSISTED IN SITU KERATOMILEUSIS). 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: Blurred Vision; Visual Impairment

  MAUDE report 21882169 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS DISSATISFIED WITH THE END RESULT. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS INCORRECT CYLINDER INITIALLY IMPLANTED FOR PATIENT NEEDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 21881126 ↗
• InjuryMar 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED MYOPIC SHIFT OF -1.00 AND LENS WAS LOOSE. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 21716027 ↗
• MalfunctionFeb 3, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, MISSING CHUNK OUT OF THE LATERAL SIDE OF THE IOL OPTIC AND ALSO HAPTIC TORN. SURGEON DISCOVERED ISSUE UNDER MICROSCOPE PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292132 ↗
• InjuryJan 13, 2025Adverse 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 VISION WAS INTOLERABLE .THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL LENS 3 MONTHS 26 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 21136160 ↗
• MalfunctionNov 18, 2024Failure to Eject; Failure to Eject

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY HAVE NOTICED THAT THE LENS GOT STUCK IN CARTRIDGE. THERE WAS A PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20708117 ↗
• InjuryNov 8, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF WHEN DELIVER INTO THE EYE THE SURGEON NOTICED A CRACK IN THE INTRAOCULAR LENS. THE LENS HAD TO BE REMOVED AND REPLACED WITH A BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT HAS CORNEAL EDEMA.

  Patient problems: Corneal Edema

  MAUDE report 20641792 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT CAME UP 2 WEEKS AFTER THE INITIAL PROCEDURE WITH COMPLAINING OF ¿VISION WAS STILL NOT GOOD. THE LENS WAS REPLACED WITH NON COMPANY MONOFOCAL IOL. AS PER PHYSICIAN'S OPINION THE TORIC IOL INCREASED THE ASTIGMATISM CAUSED OR CONTRIBUTE TO THE EVENT.

  Patient problems: Visual Impairment

  MAUDE report 20083404 ↗
• InjuryJun 27, 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 HAD DIFFICULTY WITH NIGHT VISION, FELT LIKE HAD BAD ASTIGMATISM OR SOMETHING, SEES MULTIPLE HEADLIGHTS OF ONCOMING CARS. EYES GET SORE WHEN IN FLUORESCENT LIGHTING AND HEADACHE. IOP WAS NORMAL AND RETINA WAS FINE. VISION WAS 20/40 IN RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Pain; Headache; Visual Impairment

  MAUDE report 19622791 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT AN INTRAOCULAR LENS (IOL) EXPLANT DUE TO PATIENT CAN'T READ TINY PRINT AT WORK WITH CONTACT LENS IN. THE CLINICAL REASON WAS REPORTED TO BE LENS EXCHANGE FOR DISTANCE CORRECTION TO (-0.50). . THE IOL WAS REPLACED WITH UNSPECIFIED LENS WITHIN IN A MONTH FROM INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 18639527 ↗
• MalfunctionDec 19, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS HAD A FILM. THE SURGEON SAID IT APPEARED TO BE AWAY FROM THE CENTER OF THE LENS, SO HE MADE THE CALL TO LEAVE IT IN EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 18354363 ↗
• InjuryDec 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT WAS VERY UNHAPPY. LENS WAS EXPLANTED AT SECONDARY PROCEDURE. REPLACED WITH MONOFOCAL LENS.

  Patient problems: Insufficient Information

  MAUDE report 18265947 ↗
• InjuryMar 17, 2023Adverse 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 HAD THE BEST VISION HE EVER HAD AT NEAR BUT DIFFICULTY SEEING AT DISTANCE. SURGEON RECOMMENDED HE GET -0.75 GLASSES TO SEE IF IT HELPED. THE PATIENT ENDED UP TRYING -1.00 AND COULD SEE CLEARLY. SURGEON DETERMINED PATIENT NEEDED A DIFFERENT IOL POWER SO SCHEDULED AN EXCHANGE. BUT UNABLE TO DO EXCHANGE SO DID A PIGGY BACK IOL WITH NON COMPANY -1.50 D LENS. AFTER THAT, THE PATIENT HAD DIFFICULTY SEEING AT NEAR AND HAS A LIGHT THAT COMES IN THE SIDE OF HIS EYE WHEN HE WAS APPROACHING A LIGHT SOURCE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 16565898 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS IMPLANTATION, THE PATIENT EXPERIENCED MONOCULAR DIPLOPIA. THE LENS WAS EXPLANTED AND REPLACED WITH A MONOFOCAL LENS WITHIN 2 MONTHS OF THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 15741916 ↗