Clareon CNWTT0 (UDI 00380652408028)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652408028), received between Aug 2, 2022 and Oct 23, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND HALOS WHEN DRIVING AT NIGHT AND THE VISION WAS DECREASED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT EXPLANTED IOL WITH PATIENT REASON WAS SIGNIFICANT GLARE AND HALOS DRIVING AT NIGHT AND DECREASED VISION AND CLINICAL REASON WAS RESIDUAL PRESCRIPTION CAUSING DECREASED VISION AND HALOS. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 6 MONTHS 1 DAY FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 23365781 ↗
• MalfunctionSep 18, 2025Failure to Fold; Inaccurate Delivery; Failure to Fold; Inaccurate Delivery

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS (IOL) DID NOT FOLD PROPERLY. IT WAS VERY DIFFICULT TO PUSH DOWN THE CHUTE OF THE CARTRIDGE. THE SURGEON TRIED TO INSERT THE IOL INTO THE EYE, BUT IT WAS STUCK IN THE TEMPORAL K WOUND. CONSEQUENTLY, THE SURGEON REMOVED THE IOL AND PROCEEDED TO IMPLANT A BACKUP LENS DURING THE INITIAL PROCEDURE. ACCORDING TO THE ADDITIONAL INFORMATION PROVIDED, THE INCIDENT OCCURRED DURING SURGERY. THE INTRAOCULAR LENS (IOL) BECAME STUCK HALFWAY THROUGH THE TEMPORAL CLEAR CORNEAL INCISION AND WAS SUBSEQUENTLY REMOVED. THE SURGEON REPORTED THAT THE CAUSE OF THE EVENT REMAINS UNKNOWN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082903 ↗
• MalfunctionMar 21, 2025Break; Failure to Deliver; Break; Failure to Deliver

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE LENS GOT STUCK AND HAPTIC WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE HAPTIC BROKE WHILE BEING PUSHED OUT OF THE CARTRIDGE WITH THE LENS INSERTER. THE PROCEDURE WAS COMPLETED WITH THE BACKUP LENS. NO PATIENT CONTACT WAS REPORTED. SURGEON DOES NOT BELIEVE ISSUE WAS WITH PRODUCT BUT ISSUE WITH THE LENS INSERTER GETTING STUCK UNDER THE HAPTIC, WHICH CAUSED IT TO TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662530 ↗
• InjuryNov 19, 2024Adverse 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 REASON BEING REDUCED UNCORRECTED VISION AT DISTANCE AND DEBILITATING HALOS, FROM ALL CARS ALL DAY LONG (DAY AND NIGHT) AND CLINICAL REASON FOR EXPLANT BEING REDUCED BEST CORRECTED VISUAL ACUITY WHICH WAS AFFECTING HER ACTIVITIES OF DAILY LIVING. PATIENT ALSO EXPERIENCED GLARE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM. THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL COMPANY LENS.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20721355 ↗
• InjuryNov 6, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS TRAILING HAPTIC HAD TORN DURING IMPLANTATION. DESPITE THIS SITUATION, IT WAS POSSIBLE TO IMPLANT IT IN THE CAPSULE, SO IT WAS IMPLANTED AS IT WAS AND PUT UNDER OBSERVATION. HOWEVER, DURING A CHECK-UP FOUR DAYS LATER, DISPLACEMENT OF THE LENS WAS CONFIRMED. THE NEXT DAY, THE LENS WAS EXPLANTED IN A RE-OPERATION, AND A NEW COMPANY LENS OF THE SAME MODEL WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED PATIENT VISUAL ACUITY WAS GOOD AFTER THE REPLACEMENT SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 20620397 ↗
• InjuryOct 3, 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 WAS NEVER ABLE TO SEE DISTANCE, NEAR OR INTERMEDIATE AND SURGEON REFUSED TO PROVIDE GLASSES OR RESOLUTION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20358592 ↗
• InjuryDec 8, 2022Material Opacification; Application Program Problem: Power Calculation Error; Material Opacification; Application Program Problem: Power Calculation Error

  A NON HEALTH CARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED RINGS AND SIGNIFICANT PROBLEMS WITH HALOS/LIGHTS SINCE SURGERY. THE LENS WAS EXPLANTED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE AFTER 15 DAYS. THE CLINICAL REASON FOR THE EXPLANT WAS NO SIGNIFICANT CLOUDINESS OF INTRAOCULAR LENS. ADDITIONAL INFORMATION RECEIVED AS THE PATIENT EXPERIENCED POST ONE WEEK OF SURGERY THE LIGHTS, TRAFFIC LIGHTS, STREET LIGHTS, ALL LIGHTS WERE AWFUL. THE HALOS WERE SO BAD AND COULD NOT ABLE TO DRIVE AT NIGHT. VISION WAS GOOD BUT COULD NOT STAND THE LIGHTS.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 15938595 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL), UPON EXAMINATION, INCREASED INTRAOCULAR PRESSURE WAS FOUND AT 30 MMHG. THE PATIENT TOOK TABLETS 2 TIMES ORALLY FOR 2 DAYS, AND NORMAL INTRAOCULAR PRESSURE WAS CONFIRMED IN THE FOLLOWING WEEK. THIS IS A STUDY FILE. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 15147862 ↗