Clareon CNWTT0 (UDI 00380652408103)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652408103), received between Aug 16, 2022 and Aug 20, 2026 — classified as 13 injuries, 5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Break

  A health care professional reported that during an intraocular lens (IOL) implant procedure, the haptic was broken. The lens was removed from the patient eye and a backup lens of same model and diopter was implemented to complete the procedure on the same day. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50344881 ↗
• InjuryMar 7, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. CLINICAL REASON FOR EXPLANT CYSTOID MACULAR EDEMA LEFT EYE. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS 05 MONTHS 24 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE SURGEON'S OPINION, THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT THE PATIENT WAS UNABLE TO TOLERATE LENS AND DEVELOPED AN ABNORMAL RETINA WITH AN EPIRETINAL MEMBRANE, LAMELLAR HOLE, AND MILD CYSTOID MACULAR EDEMA. A MULTIFOCAL LENS REDUCES LIGHT TRANSMISSION WHICH MAY ALSO AFFECT VISION QUALITY. MONOFOCOAL LENS WAS NEEDED TO IMPROVE CLARITY.

  Patient problems: Blurred Vision; Eye Injury; Macular Edema; Retinal Tear

  MAUDE report 24539867 ↗
• MalfunctionDec 25, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE FOUND LENS HAD A SCRATCH ON IT. SO, LENS WAS OPENED BUT NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23892080 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED A LENS POWER CHANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS LENS POWER CHANGE, UNEXPECTED TARGET REFRACTION. LENS WAS EXPLANTED AND REPLACED WITH UNSPECIFIED LENS.

  Patient problems: Visual Impairment

  MAUDE report 23692913 ↗
• InjuryNov 18, 2025Adverse 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 GLARE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 05 MONTHS FOLLOWING THE INITIAL PROCEDURE.

  Patient problems: Visual Disturbances

  MAUDE report 23581373 ↗
• MalfunctionNov 3, 2025Particulates; Material Split, Cut or Torn; Particulates; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS IMPLANTATION PROCEDURE, DURING EXAMINATION SOME PARTICLE¿S STRUCTURE AND CRACK LIKE STRUCTURE WAS NOTICED IN THE OPTIC OF THE LENS. THE PATIENT'S IMMEDIATE POST-OP WAS 6/9, AND IT WAS AFFECTING THE VISION. AS PER THE SURGEON'S OPINION IT WAS A LENS BURST DUE TO WHICH THE PATIENT DID NOT RECEIVED ANY DESIRED OUTCOMES. HENCE THE SURGEON PLANNED TO DO AN EXPLANT OF THE LENS. THE CURRENT PATIENT CONDITION WAS SYMPTOMS STILL CONTINUING.

  Patient problems: Visual Impairment

  MAUDE report 23452757 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AFTER SURGERY THE PATIENT EXPERIENCED HAZY VISION, GLARE AROUND LIGHTS AND POSITIVE DYSPHOTOPSIA. THE IOL WAS EXPLANTED AND EXCHANGED WITH A NON-COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE. NO PATIENT IMPACT WAS REPORTED TO THE PATIENT. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 21146953 ↗
• InjuryOct 4, 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 RIGHT EYE (OD) BIGGEST ISSUE WAS HALOS AROUND LIGHTS AT NIGHT WAS SEVERE AND HAVE NOT IMPROVED AND WAS PROBABLY SOMEWHAT WORSEN RIGHT AFTER SURGERY. THE PATIENT CANNOT DRIVE AT NIGHT AT ALL AND HAD COMPLETELY STOPPED DRIVING AT NIGHT BECAUSE OF THE HALOS. THE PATIENT TRIED EYE DROPS BUT NEITHER ONE HELPED AT ALL AND SEEMED TO MAKE VISION LESS CLEAR OVERALL AND EVEN SEES HALOS AROUND LIGHTS DURING THE DAY BUT NOT AS DEBILITATING AS THE NIGHT. THE PATIENT ALSO EXPERIENCED DRY EYE SYNDROME AND HYPERTROPHIC DISORDER OF THE SKIN. AS PER SURGEON THERE WERE POSTERIOR CAPSULE (PC) WRINKLES AND THERE WAS NO POSTERIOR CAPSULAR OPACIFICATION, AND IT WAS HIGHLY DOUBTFUL ANY POSTERIOR CAPSULAR WRINKLY WOULD BE THE CAUSE OF THIS TYPE OF SEVERE HALO. YAG POSTERIOR CAPSULAR THEREFORE MOSTLY LIKELY WOULD NOT HELP THAT PATIENT SO SURGEON, WISHED TO PROCEED WITH INTRAOCULAR LENS (IOL) EXCHANGE WITH NON-COMPANY LENS BUT WAS UNSURE OF WHAT POWER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Dry Eye(s); Halo; Skin Disorders

  MAUDE report 20372529 ↗
• MalfunctionAug 7, 2024Material Deformation; Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS LOOKED DAMAGED WHEN IMPLANTED. THE LENS WAS EXPLANTED, AND PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19926982 ↗
• InjuryMay 14, 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 EXPERIENCED BLURRY VISION AND GLARE FROM STREET LIGHTS AND HEADLIGHTS. THE PATIENT WAS UNABLE TO DRIVE AT NIGHT. THE SURGEON WAS UNSURE OF CAUSE AND SYMPTOMS AND SAID LENS WAS POSITIONED PROPERLY. THE PATIENT WAS TRYING DROPS FOR DRY EYE AND NEW GLASSES FOR IMPROVED VISION.

  Patient problems: Blurred Vision; Halo; Posterior Capsule Opacification; Visual Disturbances; Vitreous Floaters

  MAUDE report 19310156 ↗
• InjuryMar 28, 2024Adverse 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, PATIENT EXPERIENCED WAXY VISION .THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT.THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18992339 ↗
• InjuryJan 10, 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, PATIENT UNDERGONE CATARACT SURGERY A YEAR AGO IN BOTH EYES AND HER VISION IS BLURRY, FOGGY SINCE SHE DID HER SURGERY,BY EVENING, SHE CAN'T EVEN READ. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18482687 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED A POOR VISUAL OUTCOME SINCE HER CATARACT SURGERY 9+ MONTHS AGO. SHE HAD DISCUSSED THIS WITH HER SURGEON AND HE TELLS HER TO BE PATIENT. SHE CAN'T SEE STREET SIGNS UNTIL SHE WAS ON TOP OF THEM OR TOO LATE TO TURN, MISSES STREETS. READING PRINT AND NUMBERS WAS DIFFICULT. SHE READS VERY SLOWLY. DOES NOT ENJOY READING ANYMORE. CANNOT DO CRAFT WORK. SHE HAD TROUBLE BALANCING HER CHECKBOOK BECAUSE IT WAS DIFFICULT TO SEE NUMBERS. WAS TOLD SHE WOULD NOT NEED GLASSES. THE DOCTOR GAVE HER A GLASSES PRESCRIPTION AT HER LAST VISIT. EVERYTHING WAS BLURRY. LIGHTS HAVE GLARE AND STARBURSTS AROUND THEM. SURGEON HAD NOT GIVEN HER ANY GOOD REASON WHY SHE CANNOT SEE WELL YET. IT HAD BEEN 9 MONTHS. SHE HAD SEEN THE DOCTOR 14 TIMES. SHE HAD ALOPECIA AND WEARING GLASSES WAS VERY UNCOMFORTABLE UNDER HER WIGS. SHE HAD A PRIOR HISTORY OF OVARIAN CANCER THAT WAS SUCCESSFULLY TREATED ALONG WITH MINIMAL BRAIN MET AND A SMALL AMOUNT ON HER LOWER EYELID WHICH WAS EXCISED. HER DOCTOR ONLY TELLS HER TO BE PATIENT AND USE ARTIFICIAL TEARS TID OU. SHE DID NOT HAVE ANY KNOWN PRE-EXISTING OCULAR CONDITIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE SHE

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 18214264 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED A POOR VISUAL OUTCOME SINCE HER CATARACT SURGERY 9+ MONTHS AGO. SHE HAD DISCUSSED THIS WITH HER SURGEON AND HE TELLS HER TO BE PATIENT. SHE CAN'T SEE STREET SIGNS UNTIL SHE WAS ON TOP OF THEM OR TOO LATE TO TURN, MISSES STREETS. READING PRINT AND NUMBERS WAS DIFFICULT. SHE READS VERY SLOWLY. DOES NOT ENJOY READING ANYMORE. CANNOT DO CRAFT WORK. SHE HAD TROUBLE BALANCING HER CHECKBOOK BECAUSE IT WAS DIFFICULT TO SEE NUMBERS. WAS TOLD SHE WOULD NOT NEED GLASSES. THE DOCTOR GAVE HER A GLASSES PRESCRIPTION AT HER LAST VISIT. EVERYTHING WAS BLURRY. LIGHTS HAVE GLARE AND STARBURSTS AROUND THEM. SURGEON HAD NOT GIVEN HER ANY GOOD REASON WHY SHE CANNOT SEE WELL YET. IT HAD BEEN 9 MONTHS. SHE HAD SEEN THE DOCTOR 14 TIMES. SHE HAD ALOPECIA AND WEARING GLASSES WAS VERY UNCOMFORTABLE UNDER HER WIGS. SHE HAD A PRIOR HISTORY OF OVARIAN CANCER THAT WAS SUCCESSFULLY TREATED ALONG WITH MINIMAL BRAIN MET AND A SMALL AMOUNT ON HER LOWER EYELID WHICH WAS EXCISED. HER DOCTOR ONLY TELLS HER TO BE PATIENT AND USE ARTIFICIAL TEARS TID OU. SHE DID NOT HAVE ANY KNOWN PRE-EXISTING OCULAR CONDITIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE SHE

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 18214221 ↗
• MalfunctionNov 27, 2023Failure to Eject; Failure to Eject

  A NURSE REPORTED THAT DURING INTRAOCULAR LES (IOL) IMPLANTATION, THE SURGEON HAD TROUBLE EJECTING LENS. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18208348 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT AN INTRAOCULAR LENS (IOL) EXPLANTED IN A SECONDARY PROCEDURE. THE REASON WAS NOT SPECIFIED. THE IOL WAS REPLACED WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17972619 ↗
• InjuryAug 3, 2023Adverse 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 EXPERIENCED BLURRED VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS HALOS AND VISUAL DISCOMFORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 17451738 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED MULTIPLE SEVERE SIDE EFFECTS I.E., NIGHT BLINDNESS, SEVERE GLARE, FOGGY BLURRY VISION, FEEL OF A VEIL OVER EYES, DEPTH PERCEPTION PROBLEMS, QUIVER FEEL IN EYES, DECREASE IN VISION CLARITY. ADDITIONAL INFORMATION RECEIVED IN WHICH CONSUMER ALSO STATED THAT DRIVING WAS TREACHEROUS FROM DUSK TO DARK, CAR HEADLIGHTS LOOK LIKE HUGE BLOBS OF LIGHTS WITH RINGS AND STARBURSTS WITHOUT BEING ABLE TO DETERMINE IF THE LIGHT WAS SINGLE LIGHT OR 2 HEADLIGHTS AND CANNOT EVEN DETERMINE IF THE VEHICLE IS A MOTORCYCLE, CAR, PICKUP TRUCK OR SEMI-TRUCK OR IF THE VEHICLE IS PARTIALLY IN THE LANE. THE DAYTIME DRIVING WAS ALSO AFFECTED, AND CARS ARE BLURRY AS WELL AS ROAD SIGNS. CONSUMER CAN¿T READ THE SIGNS UNTIL ALMOST NEXT TO THEM, AND CANNOT READ A LICENSE PLATE IN FRONT, UNLESS CONSUMER STOPPED IN TRAFFIC OR AT A LIGHT. THE CONSUMER BECAME ANXIOUS WHILE DRIVING. EVEN IN THE KITCHEN TABLE THE PATIENT NOT ABLE TO SEE STOVE OR MICROWAVE WHICH IS 15 FEET AWAY. NO FURTHER INFORMATION AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 15233576 ↗