Clareon CNWTT0 (UDI 00380652408059)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652408059), received between Jun 21, 2022 and Mar 16, 2026 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT'S VISION WAS SMUDGY AND EXPERIENCED HALOS DUE TO THAT THE PATIENT CANNOT DRIVE AT NIGHT. SURGEON TRIED LASER, AND ALSO PRESCRIBED SOME EYE DROPS POST SURGERY, WHICH HELPED THE PATIENT TO SOME EXTENT. TWO WEEKS AGO, THE PATIENT SAW AN EYE CARE PROVIDER FOR THE LAST TIME AND NOW THE SURGEON SUGGESTED FOR THE GLASSES. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS 1 OF 2.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24604691 ↗
• MalfunctionDec 29, 2025Failure to Deliver; Scratched Material; Failure to Deliver; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE PUSHER WENT UNDER THE LENS AND MISSED ENGAGING THE LENS. POTENTIAL SCRATCH ON LENS AND NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907000 ↗
• MalfunctionMay 13, 2025Failure to Deliver; Failure to Deliver

  A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE INJECTOR DIDNOT PUSH OUT THE LENS PROPERLY AND END UP THE LENS STUCK IN THE CARTRIDGE. PHYSICIAN WORRIED, THE OPTIC WOULD BE SCRATCHED DUE TO THIS HICCUP AND DECIDED NOT TO PROCEED IMPLANTATION WITH THE LENS. DOCTOR CHANGED ANOTHER INJECTOR AND USED THE SAME POWER, SAME MODEL BACK UP LENS TO CONTINUE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 22009200 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER SURGERY THE PATIENT EXPERIENCED CIRCULAR RINGS DESCRIBED AS DIAMOND NECKLACES AROUND LIGHTS. SYMPTOMS HAVE BEEN CONTINUALLY DOCUMENTED AND MONITORED AND IT WAS EXPECTED THAT SYMPTOMS WOULD IMPROVE AS THE SUBJECT ADJUSTED TO THE LENSES. SUBJECT IS STILL EXPERIENCING VISUAL DISTURBANCES THAT HE WAS UNHAPPY WITH AND WAS BROUGHT IN FOR AN UNSCHEDULED VISIT TO ADDRESS THEM. HE HAS BEEN OFFERED AN EXPLANT MULTIPLE TIMES AND HAS CONTINUALLY REFUSED. PATIENT ALSO HAD THE LIMBAL RELAXING INCISIONS.

  Patient problems: Visual Disturbances

  MAUDE report 21065728 ↗
• InjuryMar 15, 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 LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS 16 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18911279 ↗
• MalfunctionFeb 22, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN LENS WAS INSERTED A SCRATCH WAS NOTED. THE LENS CUT OUT AND REPLACED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758759 ↗
• InjuryJan 31, 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 LENS MODEL BUT HALF A DIOPTER MORE POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Visual Impairment

  MAUDE report 18615020 ↗
• InjuryOct 6, 2023Break; Break

  A PHYSICIAN REPORTED THAT ABOUT A WEEK AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT'S REFRACTION TURNED NEAR-SIGHTED WITH VALUE MORE THAN -1D. ALTHOUGH IT WAS NOT NOTICED, THE PHYSICIAN SUSPECTED THAT THERE WERE CRACKS IN THE HAPTICS WHICH CAUSED THE IOL TO BECOME UNSTABLE. HOWEVER, THE PHYSICIAN WAS UNCLEAR WHETHER THIS OCCURRED BEFORE THE SURGERY OR DURING IMPLANTATION. DURING THE FOLLOW-UP CHECKUP ONE DAY AFTER THE SURGERY, THE PATIENT TOLD THAT THERE WAS DULL PAIN SOMETIMES AND TOOK PAINKILLERS TWICE A DAY. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER COMPANY LENS IN A SECONDARY PROCEDURE. IT WAS DIFFICULT TO REPLACE THE IOL DURING SURGERY AND AS A RESULT, CORNEAL EPITHELIAL DETACHMENT OCCURRED WHICH RESULTED IN POOR VISUAL ACUITY AND UNSTABLE REFLEX. ACCORDING TO SURGEON, THE VISUAL ACUITY- WOULD GET BETTER IF THE CORNEAL CONDITION CALMS DOWN. ADDITIONAL INFORMATION WAS RECEIVED. IN THE DOCTOR'S OPINION, IT WAS CONSIDERED THAT THE EVENTS (PAIN, SWELLING, BLURRED VISION, DESCEMET'S FOLDS) WERE NOT CAUSED BY THE REPLACEMENT IOL, THOSE WERE CAUSED BY THE INVASIVENESS OF IOL REPLACEMENT SURGERY. IN ADDITION, ALL EVENTS HAVE BEEN RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Eye Pain; Visual Impairment

  MAUDE report 17886006 ↗
• MalfunctionJul 13, 2023Crack; Appropriate Device Problem Term/Code Not Available; Crack; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THERE WAS LOADING ERROR AND THE LENS WAS CRACKED. THERE WAS PATIENT CONTACT.

  Patient problems: Insufficient Information

  MAUDE report 17314320 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT WHEN A PATIENT UNDERWENT POSTERIOR CAPSULOTOMY A FEW MONTHS AFTER HAVING AN INTRAOCULAR LENS (IOL) IMPLANTED, IT WAS DISCOVERED THAT THE CELLS WERE PROLIFERATING ON THE ANTERIOR LENS CAPSULE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17037257 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, PATIENT DIDN'T FEEL THE GOOD VISION AT FAR, INTERMEDIATE, AND NEAR DISTANCES. THE CAUSE OF THE NON-IMPROVED VISUAL ACUITY COULD NOT BE FOUND, IT WAS JUDGED THAT THE PATIENT COULD NOT ADAPT TO THE MULTIFOCAL IOL, AND EXCHANGED WITH THE MONOFOCAL IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 14772767 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT DIDN'T FEEL THE GOOD VISION AT FAR, INTERMEDIATE, AND NEAR DISTANCES. THE CAUSE OF THE NON-IMPROVED VISUAL ACUITY COULD NOT BE FOUND, IT WAS JUDGED THAT THE PATIENT COULD NOT ADAPT TO THE MULTIFOCAL IOL, AND EXCHANGED WITH THE MONOFOCAL IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14754351 ↗