Clareon CNWET0 (UDI 00380652405232)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652405232), received between May 9, 2023 and Mar 24, 2026 — classified as 12 injuries, 8 malfunctions.

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

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Product Quality Problem

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24679581 ↗
• MalfunctionMar 23, 2026Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY HAPTIC WAS TORN WHILE IMPLANTATION. IN THE SURGEON'S OPINION, THE IOL COULD BE THE REASON OF THE EVENT, SURGEON CUT THE IOL AND EXPLAINED IT DURING INITIAL PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY ON THE SAME DAY WITH ANOTHER IOL. CURRENT PATIENT CONDITION WAS SATISFACTORY.

  Patient problems: Insufficient Information

  MAUDE report 24663722 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION PERFORMANCE WAS UNACCEPTABLE. THE LENS WAS EXPLANTED AND REPLACED WITH UNSPECIFIED LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS INTOLERABLE OPTICAL ARTIFACTS / NEGATIVE DYSTOPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision

  MAUDE report 24605003 ↗
• MalfunctionMar 7, 2026Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT WHILE LOADING THE LENS HAPTIC LOOKED UNUSUAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24541106 ↗
• MalfunctionDec 22, 2025Inaccurate Delivery; Scratched Material; Inaccurate Delivery; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED A LENS WITH SCRATCH. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT, LENS WAS LOADED AND WAS ABOUT TO BE INSERTED, IT WAS STUCK HALFWAY, UPON TAKING IT OUT OBSERVED SCRATCH ON LENS. PROCEDURE WAS COMPLETED ON THE SAME DAY WITH DIFFERENT MODEL COMPANY LENS. THERE WAS PATIENT CONTACT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862695 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY DISTANCE VISION. CLINICAL REASON BEING MENTIONED AS UNEXPECTED REFLECTED OUTCOME. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23348980 ↗
• InjurySep 9, 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, PATIENT EXPERIENCED BLURRY VISION, SHADOWS, DOUBLE VISION. CLINICAL REASON FOR EXPLANT MENTIONED AS NEGATIVE DYSPHOTOPSIA. THE LENS WAS PLANNED TO EXPLANT AND REPLACE WITH ATIOL. ADDITIONAL INFORMATION RECEIVED THAT PATIENT ALSO EXPERIENCED CURVED, DISTORTED IMAGES, LINE IN PERIPHERAL VISION. THE LENS WAS EXPLANTED 8 MONTHS FOLLOWING THE INITIAL PROCEDURE. THE PATIENT SYMPTOMS WERE RESOLVED AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Disturbances

  MAUDE report 23003592 ↗
• MalfunctionMay 6, 2025Failure to Deliver; Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION THAT, THE LENS JAMMED IN INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21967043 ↗
• InjuryApr 25, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN OPENING A LENS SURGEON FOUND ONE OF THE LENSES DISLOCATED AND WAS UNABLE TO COMPLETE THE SURGERY AND OPTED TO LEAVE THE PATIENT APHAKIC. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING A SECOND TIME SURGERY WAS PERFORMED AND THE PATIENT WAS PRESCRIBED WITH ANTIBIOTIC, CORTICOSTEROID AND NSAID (NONSTEROIDAL ANTI-INFLAMMATORY DRUG) TREATMENT. THE PATIENT SYMPTOMS WERE RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 21911483 ↗
• MalfunctionMar 27, 2025Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED DURING LOADING. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 21709178 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT 2 AND HALF A DIOPTER LESS POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Visual Impairment

  MAUDE report 21444773 ↗
• InjuryJul 24, 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, ASIDE FROM HER NIGHT VISION IMPROVING, HER VISION WAS LESS THAN STELLAR. HER CLOSE-UP VISION WAS TERRIBLE. SHE WAS VERY DISSATISFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT WAS HOLDING, OUT BEING PATIENT ABOUT HER EYES. SHE WAS TOLD THE NEW LENSES NEED TO SETTLE IN THE LENS CAPSULES. HER CLOSE-UP VISION WAS HORRIBLE. SHE WAS TOLD TO BUY READING GLASSES TO READ UP CLOSE AND OVER TIME HER CLOSE-UP VISION WOULD IMPROVE. IT HAS NOT. HER DISTANCE VISION WAS NOT THAT GREAT EITHER. SHE WAS HOPING THAT SHE WOULD BE ABLE TO COMFORTABLY READ SUBTITLES ON THE TV WATCHING A FOREIGN FILM AND SHE COULD NOT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE PATIENT VISION WAS 20/30 UNCORRECTED AND J10 NEAR. SHE WAS TOLD TO USE READERS AS NEEDED AND FOLLOW-UP WITH SURGEON. SHE HAS NOT BEEN BACK, SO THE PATIENT CURRENT VISION OR REFRACTION WAS UNKNOWN. THE PATIENT WAS A LOW MYOPE (AROUND -1.50D) PRIOR TO SURGERY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 19818033 ↗
• InjuryJul 23, 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, ASIDE FROM HER NIGHT VISION IMPROVING, HER VISION WAS LESS THAN STELLAR. HER CLOSE-UP VISION WAS TERRIBLE. SHE WAS VERY DISSATISFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT WAS HOLDING, OUT BEING PATIENT ABOUT HER EYES. SHE WAS TOLD THE NEW LENSES NEED TO SETTLE IN THE LENS CAPSULES. HER CLOSE-UP VISION WAS HORRIBLE. SHE WAS TOLD TO BUY READING GLASSES TO READ UP CLOSE AND OVER TIME HER CLOSE-UP VISION WOULD IMPROVE. IT HAS NOT. HER DISTANCE VISION WAS NOT THAT GREAT EITHER. SHE WAS HOPING THAT SHE WOULD BE ABLE TO COMFORTABLY READ SUBTITLES ON THE TV WATCHING A FOREIGN FILM AND SHE COULD NOT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE PATIENT VISION WAS 20/30 UNCORRECTED AND J10 NEAR. SHE WAS TOLD TO USE READERS AS NEEDED AND FOLLOW-UP WITH SURGEON. SHE HAS NOT BEEN BACK, SO THE PATIENT CURRENT VISION OR REFRACTION WAS UNKNOWN. THE PATIENT WAS A LOW MYOPE (AROUND -1.50D) PRIOR TO SURGERY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 19806041 ↗
• InjuryJul 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED STARBURSTS AND SHADOWS. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT MENTIONED AS POSITIVE DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN RECEIVED PATIENT ALSO EXPERIENCED NEGATIVE DYSPHOTOPSIA, SCATTER OFF LIGHTS. THE IOL WAS EXCHANGED WITH ANOTHER COMPANY LENS.

  Patient problems: Visual Disturbances

  MAUDE report 19786901 ↗
• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH MYOPIC OUTCOME. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 MONTHS 21 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS REFRACTIVE SURPRISE POST LASIK. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 19403407 ↗
• InjuryJan 19, 2024Application Program Problem: Power Calculation Error; Application Program Problem: Power Calculation Error

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 14 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS INCORRECT LENS POWER IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 18543682 ↗
• MalfunctionNov 8, 2023Crack; Crack

  A NON-HEALTH CARE REPORTED THAT, FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REGISTERED NURSE HELPED INSERT AN IOL INTO THE INJECTOR AND WHEN PHYSICIAN WAS GOING TO INJECT IOL INTO, HE NOTICED A CRACK IN THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE ONLY DETAIL NOTED WAS THAT THE METAL PLUNGER WAS NOT BEHIND THE LENS OPTIC BUT WAS VERY SLIGHTLY ADVANCED AND OVERLAPPING THE EDGE OF THE OPTIC. AS SOON AS THE IMPLANT HAD ENTERED THE EYE, THERE WERE 2 SHORT LINEAR CRACKS NOTED IN THE OPTIC. AS A RESULT, THE IMPLANT HAD TO BE REMOVED AND THE SURGEON LOADED A REPLACEMENT LENS.

  Patient problems: Insufficient Information

  MAUDE report 18091781 ↗
• InjuryJun 26, 2023Break; Failure to Align; Break; Failure to Align

  A NURSE REPORTED THAT AFTER INTRA-OCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD DOUBLE VISION AND WAS VIEWING THROUGH THE IOL EDGE BECAUSE THE IOL HAD SUBLUXED. THE HAPTIC WAS FOUND TO BE AMPUTATED BUT WAS UNCLEAR HOW THAT HAPPENED. AT FIRST IT WAS ASSUMED THAT DUE TO ZONULAR DE-HISCENCE THE IOL WOULD NOT POSITION WELL. THE IOL APPEARED TO BE POSITIONED CORRECTLY AFTER THE SECOND SURGERY WHEN THE CAPSULAR TENSION RING (CTR) WAS IMPLANTED, HOWEVER ON POST-OPERATIVE DAY 1 (POD1) IT WAS DISCOVERED TO BE SUBLUXED ONCE MORE. AS A RESULT, THE PATIENT UNDERWENT ADDITIONAL SURGERY, DURING WHICH IRIS HOOKS WERE EMPLOYED AND AN AMPUTATED HAPTIC WAS DISCOVERED TO BE THE PROBLEM. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE WITHOUT ANY COMPLICATIONS. ACCORDING TO ADDITIONAL INFORMATION IMPLANTATION WAS DONE IN PATIENT'S LEFT EYE. THE LOADER MIGHT HAVE ALSO CONTRIBUTED TO THE LEFT EYE PROBLEMS. A REPLACEMENT LENS MADE BY THE COMPANY WAS USED. AFTER CHANGING LENSES, THE PATIENT'S PROBLEMS WERE SOLVED.

  Patient problems: Visual Disturbances

  MAUDE report 17199127 ↗
• InjuryMay 9, 2023Crack; Crack

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT MEDICAL INTERVENTION LIKE INCISION ENLARGED WAS REQUIRED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 3 OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896634 ↗
• MalfunctionMay 9, 2023Crack; Crack

  AN OPHTHALMIC SURGEON REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE SCRATCHED. ADDITIONAL INFORMATION WAS RECEIVED STATING CRACK WAS NOTED ON INTRAOCULAR LENS IMPLANTATION, BUT ULTIMATELY DECIDED TO LEAVE INTRAOCULAR LENS IMPLANTED BASED ON LOCATION OF CRACK. THERE WAS NO PATIENT HARM REPORTED. PATIENT'S SYMPTOMS WERE RESOLVED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 4 OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896435 ↗