Clareon CNWET0 (UDI 00380652405256)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380652405256), received between Sep 27, 2023 and Sep 13, 2026 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2026No Apparent Adverse Event

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 50747048 ↗
• MalfunctionApr 10, 2026Failure to Deliver; Scratched Material

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, WHILE LOADING THE LENS WAS SCRATCHED. THERE WAS NO PATIENT CONTACT AND THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED AND IT STATES THAT THE SURGEON REPORTS A LOT OF RESISTANCE WHEN TRYING TO RELEASE LENS. IN THE SURGEON¿S OPINION, ISSUE IDENTIFIED WHEN IT WAS GOING TO BE DISPENSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845448 ↗
• MalfunctionAug 19, 2025Break; Break

  ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE ISSUE WAS IDENTIFIED JUST PRIOR TO LOADING; THEREFORE, THE LENS WAS NOT LOADED. THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED WITH UNSPECIFIED BACKUP LENS.

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

  MAUDE report 22839597 ↗
• MalfunctionAug 9, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS MOUNTED AS INDICATED BY THE MANUFACTURER'S INSTRUCTIONS. THE LENS WAS ADVANCED WITHOUT ANY PROBLEMS. THE SURGEON INJECTED THE LENS. AT THE TIME OF INJECTION, THE FRONT HAPTIC ENTERED NORMALLY, WHILE THE REAR HAPTIC FRACTURED. THE LENS WAS REMOVED BY CUTTING IT AND REPLACED WITH ANOTHER NEW LENS OF THE SAME POWER AND REFERENCE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT COMPLICATIONS. AS PER THE SURGEON, THE PROBABLE CAUSE OF THE EVENT WAS THAT THE LENS PROBABLY GOT STUCK IN THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, CONFIRMING THAT NO TREATMENT WAS PRESCRIBED. THE PATIENT'S ISSUES RESOLVED WITHOUT HARM OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22766697 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE AFTER A WEEK OF SURGERY, THE PATIENT COMPLAINED OF A DECREASE IN VISUAL ACUITY TO 0.6 ¿ 0.7 AND DISTORTION OF OBJECTS. THE EXAMINATION OF THE FUNDUS ALSO, REVEALED MACULAR EDEMA. IN APR AND MAY, THE SURGEON CONDUCTED 2 COURSES OF ANTI-INFLAMMATORY AND DECONGESTANT THERAPY. A POSITIVE TREND WAS NOTED DURING THE CONTROL EXAMINATION. THE PATIENT'S VISION WAS RECOVERED TO 1.0 AND THERE WERE NO DISTORTIONS OF OBJECTS. ADDITIONAL INFORMATION RECEIVED AND STATES THAT PATIENT HAD MACULAR EDEMA THAT COMPLICATED INTO DYSTROPHY OF THE PHOTORECEPTOR LAYER IN FAVELA. THE PATIENT COMPLAINED OF DISCOLORATION AND CURVATURE OF OBJECTS. ON THE BACKGROUND OF ANTI-INFLAMMATORY AND DECONGESTANT THERAPY, VISUAL ACUITY RECOVERED TO 0.9. HOWEVER, COLOR DISTORTION AND CURVATURE OF OBJECTS REMAIN. AT THE MOMENT, THE PATIENT CANNOT DRIVE A CAR, HAMMER A NAIL AND TIGHTEN A SCREW (BECAUSE THE CURVATURE PREVENTS).

  Patient problems: Blurred Vision; Macular Edema; Visual Disturbances; Visual Impairment

  MAUDE report 22541237 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE REPORTED THAT, FOLLOWING AN INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT HAD UNDERGONE (YTTRIUM ALUMINUM GARNET) YAG LASER IN THE EYE AND SINCE THEN HE CAN ONLY SEE NEAR. HE WAS ENCOURAGED BY HIS SURGEON TO HAVE A SECOND OPINION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22395319 ↗
• MalfunctionMay 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED STATING THAT THERE WAS A CRACK IN THE OPTIC. LENS WAS INSERTED AND REMOVED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. AS PER THE SURGEONS OPINION THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT WAS NOTED AS, LOADING - PLUNGER WAS ABOVE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21985935 ↗
• InjuryMay 7, 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, SURGEON IMPLANTED COMPANY LENS INTO A PATIENT AND ONE WEEK POST OFF IMPLANTED ANOTHER COMPANY LENS IN SECOND EYE. JUST A LITTLE OVER ONE WEEK POST OF FROM FIRST IMPLANTATION PATIENT STARTED TO EXPERIENCE CYSTOID MACULAR EDEMA, THEN SAME THING HAPPENED WITH SECOND EYE. REGULAR POST OPERATIVE DROPS WERE NOT WORKING SO SURGEON REFERRED TO RETINAL SURGEON FOR INTRAVITREAL INJECTION (IVT) TREATMENT. SURGEON SAID NOTHING NOTEWORTHY, SURGERY WAS COMPLETED AS PER NORMAL. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, ISSUES STARTED 3 WEEKS AFTER IMPLANTATION. THE LENS STILL REMAINS IN THE PATIENT EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT.

  Patient problems: Macular Edema

  MAUDE report 21977129 ↗
• MalfunctionMay 2, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS LOADED AND ADVANCED WITHOUT DIFFICULTY. AFTER IMPLANTATION, PHYSICIAN MANEUVERED LENS IN EYE AND HAPTIC FELL OFF. LENS CUT OUT AND REMOVED AND ANOTHER LENS INSERTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE SURGEON FELT HAPTIC FELL WAS PRODUCT RELATED ISSUE. THERE WAS NO PATIENT HARM. THE SURGEON PROGNOSIS WAS EXCELLENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950601 ↗
• MalfunctionApr 30, 2025Material Opacification; Scratched Material; Material Opacification; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE SURGEON NOTICED MARK ON INTRAOCULAR LENS MARKS ON IOL AND BLUEISH GRAY FILM ON OPTIC SURFACE. THE LENS REMAINS IMPLANTED AND THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21933630 ↗
• MalfunctionDec 12, 2024Device Difficult to Setup or Prepare; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Device Damaged by Another Device

  A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF NURSE HAD AN ISSUE LOADING LENS, NOTED LENS DAMAGED AS A RESULT. DAMAGED LENS WAS NOT USED IN THE PATIENT, SECOND LENS WAS USED. PROCEDURE COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20912468 ↗
• InjuryOct 30, 2024Adverse 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 REASON WAS NOT ADAPTING TO VISION. CLINICAL REASON FOR EXPLANT WAS UNHAPPY, AND NOT ADAPTING DESPITE CORRECTION OF REFRACTIVE ERROR, AGGRESSIVE SURFACE MANAGEMENT. THE IOL WAS EXCHANGED FOR MONOFOCAL NONCOMPANY LENS 10 MONTHS 3 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE SYMPTOMS WERE NOT RESOLVED POST REPLACEMENT. AFTER REPLACEMENT WITH MONOFOCAL LENS PATIENT HAD SOME MILD CORNEAL EDEMA.

  Patient problems: Visual Impairment

  MAUDE report 20570387 ↗
• InjuryJul 15, 2024Adverse 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 DIFFERENT MODEL WITH THE SAME DIOPTER INDICATING THE CORRECT LENS WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

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

  MAUDE report 19744078 ↗
• MalfunctionJun 3, 2024Material Deformation; Scratched Material; Material Deformation; Scratched Material

  A PHYSICIAN REPORTED THAT DURING SURGERY, THEY NOTICED THAT SURGEON NOTICED THESE MARKS ON THE ANTERIOR OPTIC OF THE IOL. HE FELT AS THOUGH THERE WAS A COATING ON THE IOL AND THE COATING CAME OFF WHILE HE WAS ROTATING THE IOL WITH THE BI-MANUAL IRRIGATION AND ASPIRATION HANDPIECES. HE APPLIED THE SAME TECHNIQUE OF ROTATING THE IOL WITH THE BI-MANUAL I/A ON OTHER IOLS ON THE SAME DAY AND THE MARKS ON THE IOL OPTIC WERE NOT OBSERVED. HE WAS ALSO PRESENT DURING THE SURGERY AND COULD CONFIRM THAT THESE MARKINGS WERE ONLY VISIBLE ON THE LENS AND NOT CAUSED BY FORCEPS DURING IOL LENS LOADING. LENS REMAIN IMPLANTED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19448659 ↗
• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT, AFTER USING THE SAMPLE LENS, THE PATIENT'S VISION POST-SURGERY HAD SHIFTED TOWARDS MYOPIA, LEADING TO A COMPLAINT REPORT BASED ON REFRACTIVE ERROR. THE LENS HAS BEEN REPLACED WITH ANOTHER LENS. THERE IS NO INFORMATION PROVIDED ABOUT THE REPLACEMENT LENS UPON FOLLOW UP. THE FACILITY DISPOSED OF THE LENS, MAKING IT UNAVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 18392044 ↗
• InjurySep 27, 2023Defective Device; Defective Device

  A NURSE REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED OF HEADACHES. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MALFUNCTIONING IOL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE SURGEON PROGNOSIS WAS EXCELLENT AFTER EXCHANGE.

  Patient problems: Headache

  MAUDE report 17823417 ↗