Clareon™ CNWTT3 (UDI 00380652468572)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652468572), received between Nov 22, 2022 and Aug 14, 2026 — classified as 10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  A consumer reported that following an intraocular lens (IOL) implant procedure, since the surgery, the patient had experienced persistent halos, starbursts, and severe glare around lights, especially at night. These symptoms began after the implantation of lenses and have had a substantial impact on her daily life. The nighttime glare and halos make it unsafe to drive after dark, forcing her to miss evening activities and depend on family or friends for transportation. Losing the ability to drive at night has significantly reduced her independence and quality of life. Additional information has been requested, yet no new information received.There are two Medical Device Reports associated with this patient. This report is associated with the left eye.

  Patient problems: Visual Disturbances

  MAUDE report 50252257 ↗
• MalfunctionJan 16, 2026Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS DEFORMED WHEN THE IOL WAS BEING LOADED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095323 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT LENS WAS EXCHANGED WITH DIFFERENT MODEL COMPANY LENS. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS ASSOCIATED WITH RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23907672 ↗
• InjuryOct 23, 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 EXPERIENCED POOR VISION BOTH NEAR AND FAR. THE CLINICAL REASON WAS MENTIONED AS NEURO NON-ADAPTATION TO AN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL). THE IOL WAS EXPLANTED AND REPLACED WITH AN UNKNOWN ATIOL DURING A SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Blurred Vision

  MAUDE report 23367608 ↗
• MalfunctionSep 16, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED LOADING ERROR. THE HAPTIC WAS BROKEN. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23061861 ↗
• InjuryAug 21, 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 HAD POSITIVE DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 3 MONTHS AND 9 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 22857513 ↗
• InjuryOct 9, 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 HAD POOR QUALITY DISTANCE AND NEAR VISION, UNACCEPTABLE UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA), UNCORRECTED NEAR VISUAL ACUITY (UCNVA), BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA), BEST CORRECTED NEAR VISUAL ACUITY (BCNVA). THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20405821 ↗
• InjurySep 19, 2024Adverse 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 WITH HEADACHES, BLURRED VISION BOTH DISTANCE AND NEAR AND HALOS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 25 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED, PATIENT REASON AND CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DYSPHOTOPSIA.

  Patient problems: Blurred Vision; Halo; Headache; Visual Disturbances

  MAUDE report 20257835 ↗
• MalfunctionMar 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, PATIENT EXPERIENCED BLURRED VISION DUE TO IOL DISLOCATION. THE LENS EXPLANT WAS SCHEDULED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 18826259 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT COMPLAINED THAT VISION WAS NOT UP TO EXPECTATIONS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS POOR VISION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 17743930 ↗
• InjuryMar 28, 2023Adverse 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, THE PATIENT DID NOT HAD ANY CLEAR DISTANCE VISION BUT THE PATIENT CAN READ AND DRIVE WELL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, PATIENT HAD SIGNIFICANT DES (DRY EYE SYNDROME) SINCE SURGERY AND THEY'VE GIVEN HIM CORTICOSTEROID AND LUBRICANT DROPS. THE PATIENT SOUGHT OUT ANOTHER OPINION AND THEY SAID ALL LOOKS GOOD AND CENTERED. THE PATIENT WILL FOCUS ON DRYNESS FIRST, THEN ON TO ANOTHER OPINION FOR POSSIBLE IOL EXCHANGE IN THE FUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Disturbances; Visual Impairment

  MAUDE report 16626145 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT STATED HE HAD SURGERY 4-5 WEEKS AGO AND HAD TERRIBLE SIDE EFFECTS LIKE GLARE DURING DAY, HEADACHES, NAUSEA AND LOSS OF CONTRAST SENSITIVITY. PATIENT STATED HIS VISION WAS 20/20. DID NOT HAVE CATARACTS DID A CLEAR LENS EXCHANGE. HE HAD SOME CORNEAL ISSUES AFTER SURGERY AND HAD TO USE MURO 128. THIS WAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED STATING ISSUES WERE STILL PRESENT, VERY BRIGHT LARGE STARBURST, RAY BEAMS FROM 7-2 O'CLOCK POSITION, AND HUGE HALOS, LONG RANGE DISTANCE NOT AS GOOD ANYMORE AND A GRAININESS AT NIGHT. PATIENT WAS 20/20 BUT THERE WERE A LOT OF OTHER ISSUES AS DESCRIBED. IT HAD BEEN GOING ON AS OF NOW 4 MONTHS. SURGEON SAID EVERYTHING WAS PERFECT WITH THE LENS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo; Headache; Hyporesponsive to stimuli; Nausea; Visual Disturbances

  MAUDE report 16310558 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT STATED HE HAD SURGERY 4-5 WEEKS AGO AND HAD TERRIBLE SIDE EFFECTS LIKE GLARE DURING DAY, HEADACHES, NAUSEA AND LOSS OF CONTRAST SENSITIVITY. PATIENT STATED HIS VISION WAS 20/20. DID NOT HAVE CATARACTS DID A CLEAR LENS EXCHANGE. HE HAD SOME CORNEAL ISSUES AFTER SURGERY AND HAD TO USE MURO 128. THIS WAS RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo; Headache; Hyporesponsive to stimuli; Nausea; Visual Disturbances

  MAUDE report 15842856 ↗
• MalfunctionNov 22, 2022Defective Device; Scratched Material; Defective Device; Scratched Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE SURGEON IMPLANTED THE LENS, NOTICED A SCRATCH OR DEFECT IN THE CENTER OF THE IOL. IOL WAS REMOVED AND REPLACED WITH NEW IOL DURING INITIAL PROCEDURE. NO MORE INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15841854 ↗