Clareon CNWET0 (UDI 00380652405263)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652405263), received between Sep 27, 2023 and Jun 12, 2026 — classified as 11 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (4 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.

• MalfunctionJun 12, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE TRAILING HAPTIC WAS DEFECTIVE UPON IMPLANTATION INTO THE PATIENT¿S EYE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TORN HAPTIC WAS CUT OUT, REMOVED AND REPLACED WITH A NEW LENS ON THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 25485223 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. CLINICAL REASON FOR EXPLANT REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL LENS 13 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24662403 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT WAS DISSATISFIED WITH THE VISUAL OUTCOME. THE LENS WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH ANOTHER LENS DURING A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS REPORTED AS GLARE. ADDITIONAL INFORMATION WAS RECEIVED AS MYOPIC SURPRISE DUE TO THE PRIOR REFRACTIVE SURGERY.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 24483113 ↗
• MalfunctionJan 19, 2026Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, SURGEON NOTICED SPECKLES ON LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24109001 ↗
• MalfunctionDec 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A BREAK IN THE OPTIC AT THE TRANSITION TO HAPTIC WAS DISCOVERED. THE CRACK WAS DISCOVERED IMMEDIATELY DURING LENS POSITIONING. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER UNSPECIFIED LENS. IN SURGEON'S OPINION, THE CRACK WAS POSSIBLY DUE TO THE SHOOTER OR THE CARTRIDGE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED WITH SAME MODEL AND DIOPTER COMPANY LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827935 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT DOES NOT CORRECT HER VISION WITH OPTICAL AIDS AND VISUAL ACUITY (VA) RANGES ON 0.7. THE DOCTOR ATTEMPTED TO IMPROVE VA WITH A PINHOLE REFRACTION, BUT THIS DID NOT IMPROVE VISION EITHER. SINCE THE PATIENT'S SATISFACTION COULD NOT BE IMPROVED, ALL TYPES OF STUDIES WERE PERFORMED, SUCH AS CVC, OCT, AND ELECTRORETINOGRAPHY. IN ADDITION TO A COMPLETE ROUTINE OPHTHALMOLOGICAL EXAMINATION, NO POSSIBLE CAUSE WAS FOUND. THE DOCTOR ALSO PERFORMED A CAPSULOTOMY, BUT IT ONLY CORRECTED 0.7 IN BOTH EYES. THE PATIENT, HOWEVER, CONTINUES TO REPORT DISCOMFORT. WHEN THE DOCTOR LOOKED FOR UNCORRECTED RESIDUAL VISION WITH FOGGING, THERE WAS NO IMPROVEMENT (WHICH COULD INDICATE BEING VERY CLOSE TO EMMETROPIA). PHYSICIAN ALSO COMPLAINED THAT THE PATIENT HAS A SLIGHT INCREASE IN THE BLIND SPOT, BUT AUTOFLUORESCENCE AND ELECTRORETINOGRAPHY WERE NORMAL. AT FIRST, SHE HAD DIFFICULTY ADAPTING IN BOTH EYES BUT REACHED 0.9 VISUAL ACUITY. THEN IT WORSENED TO 0.7 (DECIMAL). SHE READS 0.75 WITH BOTH EYES. THE VISUAL ACUITY IS GENERALLY NOT BAD, BUT THE PATIENT REPORTS DISCOMFORT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED

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

  MAUDE report 23754311 ↗
• MalfunctionOct 27, 2025Dent in Material; Dent in Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AN UNEVEN IOL EDGE WAS NOTICED AND SURGERY WAS COMPLETED WITH THE SAME LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23390701 ↗
• InjuryAug 19, 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 HAD REFRACTIVENESS. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 28 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS REFRACTIVENESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 22839199 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED SEVERE HALO EFFECT AT NIGHT AND HEADACHES DAILY. AFTER SEVERAL WEEKS HIS VISION WAS SLOWLY DECLINED AND HAD ISSUES WITH TRANSITIONING FROM NEAR TO DISTANT VISION WITH SEVERE BLURRING. AFTER A FEW MINUTES OF READING ON HIS PHONE TRIED TO LOOK AT ANYTHING AT A DISTANCE IT TAKES 20 MINUTES TO AN HOUR FOR HIS VISION TO CLEAR UP WHERE THE PATIENT VISION WAS AGAIN CLEAR WITH NO BLURRING. THIS TRANSITION OCCURRENCES ARE DEBILITATING AND AFFECTING HIS DAILY ACTIVITIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS 2 OF 2.

  Patient problems: Blurred Vision; Headache; Visual Disturbances

  MAUDE report 22588594 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED SEVERE HALO EFFECT AT NIGHT AND HEADACHES DAILY. AFTER SEVERAL WEEKS, HIS VISION WAS SLOWLY DECLINED AND HAD ISSUES WITH TRANSITIONING FROM NEAR TO DISTANT VISION WITH SEVERE BLURRING. AFTER A FEW MINUTES OF READING ON HIS PHONE TRIED TO LOOK AT ANYTHING AT A DISTANCE IT TAKES 20 MINUTES TO AN HOUR FOR HIS VISION TO CLEAR UP WHERE THE PATIENT VISION WAS AGAIN CLEAR WITH NO BLURRING. THIS TRANSITION OCCURRENCES ARE DEBILITATING AND AFFECTING HIS DAILY ACTIVITIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS 1 OF 2.

  Patient problems: Blurred Vision; Headache; Visual Disturbances

  MAUDE report 22588275 ↗
• MalfunctionMay 13, 2025Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE IMPLANTING THE LENS DAMAGE AND DEEP SCRATCHES WERE FOUND ON LENS. THE DAMAGE WAS LOCATED ON THE PERIPHERY, SO IMPLANTED THE LENS. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NO INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011251 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED ISSUES WITH BOTH DISTANCE AND NEAR VISION. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS REFRACTIVE SURPRISE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21941150 ↗
• InjuryMar 27, 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, PATIENT DIDN'T GET CLEAR VISION, ALSO PATIENT EXPERIENCED INTRAOCULAR PRESSURE GOES UP TO 44, SWELLING ON CORNEA. PATIENT ALSO STATED EYE CARE PROVIDER WAS PRESCRIBING FLUOROQUINOLONES, CORTICOSTEROID, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAID), ARTIFICIAL TEARS, ANTI-DIARRHEAL MEDICATION, CARBONIC ANHYDRASE INHIBITORS, BETA BLOCKER, PROSTAGLANDINS ETC. PATIENT SYMPTOMS WERE CONTINUING.

  Patient problems: Corneal Edema; Intraocular Pressure Increased; Visual Impairment

  MAUDE report 21707589 ↗
• InjuryMar 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHARMACIST REPORTED THAT DURING SURGERY DOCTOR PERFORMED A PHACO ON THE PATIENT. HE SAID THAT THE SURGERY WOULD BE COMPLEX AND THAT THE PATIENT TAKES MEDICATION FOR HIS PROSTATE, WHICH WOULD MAKE THE PROCEDURE MORE DIFFICULT BECAUSE OF THE IRIS. THE SURGERY WENT WELL. WHEN THE DOCTOR PROCEEDED TO INJECT THE LENS, THE IRIS CAME OUT. THE DOCTOR HAD ALREADY INJECTED A LITTLE OF THE LENS, HE TOOK OUT THE INJECTOR AND INSERTED THE IRIS. HE PLACED UNSPECIFIED VISCOELASTIC AND TREATED THE IRIS AND THE HIGH PRESSURE IN THE EYE AGAIN. IT COULD NOT BE REPOSITIONED. THREE ATTEMPTS WERE MADE IN WHICH THE LENS WAS MANIPULATED. FINALLY, THE EYE STABILIZED A LITTLE BETTER. THE DOCTOR INJECTS THE LENS, WHICH COMES OUT WITH A BROKEN OPTIC. THE LENS WAS NOT REMOVED BECAUSE IT REMAINS STABLE IN THE EYE. IN ADDITION, IT WOULD BE MORE RISKY FOR THE PATIENT DUE TO THE CONDITIONS TO CHANGE IT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT THE INTRAOCULAR PRESSURE (IOP) WAS INCREASED FOR THE PATIENT.

  Patient problems: Intraocular Pressure Increased; Prolapse

  MAUDE report 21678938 ↗
• MalfunctionJan 3, 2025Defective Device; Defective Device

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED, IT WAS SURGEON LOADING ERROR NOT THE FAULT OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21065723 ↗
• MalfunctionNov 28, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE LENS WAS DESTROYED THE CARTRIDGE AND DAMAGED, IT WAS NOT IMPLANTED, SURGERY WAS POSTPONED. ADDITIONAL INFORMATION RECEIVED IT STATES THAT THERE WAS NO PATIENT CONTACT AND NO IMPACT TO THE PATIENT, CURRENT CONDITION WAS SATISFACTORY AND PLANNED SURGERY, POSTPONED FOR A WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20805038 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HALOS, TERRIBLE DRIVING AT NIGHT, WORSENING WITH TIME. CLINICAL REASON FOR EXPLANT WAS POSITIVE DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS MODEL 5 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE IOL WAS EXCHANGED FOR NON-COMPANY MONOFOCAL LENS MODEL.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 19826571 ↗
• InjuryJan 22, 2024Break; Break

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS TORN HAPTIC. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THERE WAS NO PATIENT HARM. THE SURGEON ALSO STATED THAT THE PROGNOSIS OF THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Insufficient Information

  MAUDE report 18551437 ↗
• MalfunctionSep 27, 2023Scratched Material; Scratched Material

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE REPORTER SUSPECT THAT THE INJECTORS ARE THE ONES THAT HAVE PRESENTED DEFECTS SINCE THE LENSES ARE VERIFIED BEFORE ASSEMBLY UNDER A MICROSCOPE AND AT THAT TIME NO DAMAGE HAS BEEN OBSERVED IN THE LENS UNTIL AFTER THAT THE INJECTOR HAS BEEN USED FOR IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17823764 ↗
• MalfunctionSep 27, 2023Scratched Material; Scratched Material

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE REPORTER SUSPECT THAT THE INJECTORS ARE THE ONES THAT HAVE PRESENTED DEFECTS SINCE THE LENSES ARE VERIFIED BEFORE ASSEMBLY UNDER A MICROSCOPE AND AT THAT TIME NO DAMAGE HAS BEEN OBSERVED IN THE LENS UNTIL AFTER THAT THE INJECTOR HAS BEEN USED FOR IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17823763 ↗