Clareon™ CNWTT3 (UDI 00380652468596)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652468596), received between Aug 1, 2022 and Sep 7, 2026 — classified as 4 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. 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.

• MalfunctionSep 7, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50647701 ↗
• InjuryMar 17, 2026Device Dislodged or Dislocated

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. DURING THE EXPLANT PROCEDURE SURGEON NOTICED TEMPORAL HAPTIC NOT POSITIONED IN BAG CORRECTLY AND POTENTIAL CAUSE FOR REFRACTIVE SURPRISE ALONG WITH ENLARGED CAPSULORHEXIS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 04 MONTHS 25 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, PATIENT REASON FOR THE BLURRED VISION WAS DUE TO A REFRACTIVE SURPRISE. THE SURGEON WAS ENGAGED TO PERFORM AN IOL EXCHANGE PROCEDURE IN RIGHT EYE, HE DID NOT PERFORM THE ORIGINAL SURGERY THE INITIAL SURGERY WAS PERFORMED IN OTHER HOSPITAL. THE HAPTIC WAS LOCATED OUTSIDE THE CAPSULAR BAG WAS AN INCIDENTAL FINDING AT THE TIME OF THE EXPLANT BY THE SURGEON. THIS WAS NOT RECORDED AT THE TIME OF THE ORIGINAL SURGERY NOR DETECTED PRIOR TO THE EXPLANT. HOWEVER, IT PROBABLY CONTRIBUTED TO THE REFRACTIVE SURPRISE AND THE PATIENT SYMPTOMS. THE PATIENT DID UNDERGO A SECOND PROCEDURE AT LEAST 5 MONTHS FOLLOWING THE ORIGINAL SURGERY AS HE COULD NOT TOLERATE THE RESIDUAL REFRACTIVE ERROR.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24618286 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE COMPANY LENS WAS REPLACED WITH THE COMPANY LENS OF DIFFERENT MODEL BUT SAME DIOPTER. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23907117 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT AFTER 1 WEEK SURGERY, THE PATIENT EXPERIENCED FEELING OF BEING PUNCHED IN THE EYE AND IS WORSE AS THE DAY PROGRESSION LIKE BRUISED. LIGHT IS VERY REALLY PAINFUL AND RED CAN SEE DISCO LIGHTS TEMPORAL. CAN SEE THE EDGE OF THE IMPLANT AND VERY BLURRY. PATIENT ALSO HAD POST OPERATIVE (PO) LASER-ASSISTED IN-SITU KERATOMILEUSIS (LASIK)SURGERY AND THEY HAVE PLANNED FOR EXPLANT. ADDITIONAL INFORMATION HAS RECEIVED IT STATES THAT THE PATIENT HAD CATARACT SURGERY AND UNHAPPY WITH VA (VISUAL ACUITY). AT ONE WEEK PO, PATIENT WAS MYOPIC AT -1.25 COULD NOT CORRECT TO CLEAR 20/20, TOOK THAT INTO CONSIDERATION WITH NEW LENS POWER, REPLACED THE COMPANY LENS WITH NON COMPANY LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE AFTER THIS NOW SHE IS +0.75 (AIMED TO CORRECT TO -1.00), NO LONGER HAS DISTORTION FROM LIGHTS. ADDITIONAL INFORMATION HAS RECEIVED IT STATES THAT THE PATIENT AND CLINICAL REASON FOR EXPLANT MENTIONED AS STEAKS OF LIGHT AND BLURRY VISION.

  Patient problems: Blurred Vision; Eye Irritation; Eye Pain; Visual Disturbances; Visual Impairment

  MAUDE report 20514401 ↗
• MalfunctionJun 10, 2024Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT NOTICED SCRATCHES ON OPTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19498415 ↗
• MalfunctionMar 28, 2024Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS THAT HAD A CRACK, LENS WAS REMOVED DURING INITIAL PROCEDURE AND USED ANOTHER ONE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18995041 ↗
• MalfunctionFeb 15, 2024Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED DUE TO A DEFECTIVE LENS INSERTION DEVICE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE LENS DID NOT SLIDE IN THE USUAL MANNER BUT WAS TIGHT. THE INSERTER'S INNER GUIDE APPARENTLY DID NOT PASS STRAIGHT THROUGH. THE PROCEDURE COMPLETED BY CHANGING THE LENS AND THE INJECTOR. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO HARM WAS CAUSED TO PATIENT, PERHAPS IT PROLONGED THE SURGERY BY A FEW MINUTES.

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

  MAUDE report 18710986 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT'S VISION WAS POOR AND IT WAS DIFFICULT TO SEE, AND THAT THE EYESIGHT HAD NOT IMPROVED. IT WAS REPORTED THAT DUE TO THE EFFECT OF ASTIGMATISM, IT MAY HAVE BEEN INCOMPATIBLE. THE SITUATION IMPROVED AFTER SINGLE FOCUS LENS WAS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT HAD POOR DISTANCE VISION AND THE PATIENT'S SYMPTOMS WERE RESOLVED POST LENS REPLACEMENT WITH A NON COMPANY LENS.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15137420 ↗