Clareon CNWTT0 (UDI 00380652408097)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652408097), received between Feb 24, 2022 and Apr 7, 2026 — classified as 16 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (3 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE SECONDARY PROCEDURE DUE TO UNSPECIFIED ISSUE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PATIENT EXPERIENCED SIGNIFICANT VISION ISSUES IN HER RIGHT EYE. AFTER A BRAIN SCAN AND ADDITIONAL TESTING THE RESULTS WAS NORMAL. IT WAS DETERMINED THAT THE LENS WAS DEFECTIVE.

  Patient problems: Visual Disturbances

  MAUDE report 24802292 ↗
• 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 WITH BLURRY VISION AND PATIENT NOT SATISFIED. THE LENS WAS EXCHANGED FOR ANOTHER NON-COMPANY LENS MODEL 03 MONTHS 10 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS OTHER VISUAL DISTRUBANCES AND CLOUDY VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 24539875 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED UNEXPECTED VISION LOSS AND GLARE AND THE LENS WAS EXCHANGED WITH ANOTHER COMPANY AND ANOTHER MODEL LENS 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 23629483 ↗
• InjuryMay 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2025, DURING A SURGICAL OPERATION, AFTER IMPLANTATION OF THE IOL, CRACKS IN THE IOL WERE DETECTED. DUE TO THE DEFECT IN THE IOL OPTICAL SYSTEM, A DECISION WAS MADE TO EXPLANT THE LENS THROUGH AN EXTENDED INCISION AND PERFORM SECONDARY IOL IMPLANTATION THE FOLLOWING DAY DUE TO THE LACK OF SUITABLE DIOPTER ON THE DAY OF SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE TARGET REFRACTION WAS ACHIEVED IN THE POSTOPERATIVE PERIOD. THE PATIENT CONDITION REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968177 ↗
• MalfunctionMar 13, 2025Dent in Material; Dent in Material

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY WHILE FOLDING THE LENS INTO THE MONARCH, THE INSTRUMENT OPERATOR NOTICED THAT THE LENS WAS DAMAGED. PROCEDURE COMPLETED BY USING THE NEW UNSPECIFIED LENS. NO COMPLICATIONS WAS REPORTED. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT DURING THE OPERATION, THE SURGEON UNPACKED THE LENS AND GAVE IT TO THE OPERATOR. SHE STARTED FOLDING IT WITH COMPANY FOLDING TWEEZERS AND WHEN THE LENS WAS HALF IN THE MONARCH, SHE NOTICED THAT THE LENS WAS DAMAGED AT THE EDGE OF THE OPTIC. AFTER CONSULTING WITH THE SURGEON, A NEW LENS WAS USED AND THIS LENS WAS KEPT FOR COMPLAINT. THERE WAS NO CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594441 ↗
• MalfunctionJan 17, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRA OCULAR LENS (IOL) IMPLANTATION PROCEDURE, LENS CAME SCRATCHED DURING IMPLANTATION ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21177400 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD BLURRY VISION, HALOS, DECREASED CONTRAST, POSITIVE DYSPHOTOPSIA, HAZY VISION AND GLARE AROUND LIGHTS. THE LENS WAS EXCHANGED WITH NON-COMPANY INTRAOCULAR LENS AFTER THE INITIAL IMPLANT PROCEDURE. PATIENT ISSUE WAS RESOLVED AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 21136795 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD VISION AND LIGHT BLUR. ALSO, VISION WAS NOT 50 PERCENT OF CORRECTED VISION. ALL EYE EXAMINATIONS WERE PERFORMED AFTER SURGERY. INCORRECT DIOPTER SURGERY WAS PERFORMED ON THE PATIENT DUE TO IRREGULAR CORNEA AND DRYNESS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE WITH UNSPECIFIED IOL. PATIENT'S VISION RELIEF AFTER EXCHANGE PROGRESSION. 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; Visual Impairment

  MAUDE report 20613848 ↗
• 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 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 20373918 ↗
• MalfunctionMar 28, 2024Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING SURGERY, LENS WAS IMPLANTED ON THE SAME PATIENT AND HAD TO BE REMOVED DUE TO A LARGE GAUGE ON THE SIDE OF THE LENS. THEY THEN CHANGED CARTRIDGES/INJECTOR IMPLANTED A 3RD LENS AND IT WAS OK. THEY PULLED THE IOLS AND THE CARTRIDGE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM. SYMPTOMS RESOLVED. THERE ARE TWO FILES ASSOCIATED WITH THIS EVENT. THIS IS 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18995258 ↗
• MalfunctionMar 26, 2024Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING SURGERY, LENS WAS IMPLANTED ON THE SAME PATIENT AND HAD TO BE REMOVED DUE TO A LARGE GAUGE ON THE SIDE OF THE LENS. THEY THEN CHANGED CARTRIDGES/INJECTOR IMPLANTED A 3RD LENS AND IT WAS OK. THEY PULLED THE IOLS AND THE CARTRIDGE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM. SYMPTOMS WERE RESOLVED. THERE ARE TWO FILES ASSOCIATED WITH THIS EVENT. THIS IS 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976985 ↗
• InjuryJan 17, 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 COMPANY LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18524293 ↗
• InjuryJan 11, 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 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 PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18491028 ↗
• InjuryJan 10, 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 PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18482096 ↗
• 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 LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18481968 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HER VISION QUALITY WAS HORRIBLE NEAR, INTERMEDIATE AND FAR, HAD HORRIBLE BLINDING HALOS, STARBURST DURING THE DAY PASSING CARS WITH LIGHTS ON AND AT WORK WITH PEOPLE'S DIGITAL COMPUTERS AND KEYBOARDS, SEVERE MIGRAINES FROM POOR VISIONS. IT WAS ALSO REPORTED THAT PATIENT QUALITY OF LIFE HAS DRAMATICALLY CHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT WAS HAVING ISSUES WITH INTERMEDIATE, DISTANCE VISION NOT CLEAR, COULD NOT SEE FACE OF CHILD IN HER LAP, OR THE LICENSE PLATE ON CARS IN FRONT OF HER, LEFT EYE WAS WORSE THAN RIGHT EYE. SHE WAS HAVING HORRIBLE HALOS AND GLARE FROM LIGHTS AT NIGHT. NEXT POST-OP APPOINTMENT WAS SCHEDULED ON (B)(6) 2023. PATIENT WAS TOLD VISION WAS 20/20. HE WAS ABLE TO REASSURE HER. HE TOLD HER TO USE BRIGHTER LIGHT WHEN TRYING TO READ PAPERS AT WORK (FLASHLIGHT USED IN OFFICE). THIS WORKED VERY WELL FOR HER. INSTRUCTED HER TO STOP STEROID DROP. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

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

  MAUDE report 17595108 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HER VISION QUALITY WAS HORRIBLE NEAR, INTERMEDIATE AND FAR, HAD HORRIBLE BLINDING HALOS, STARBURST DURING THE DAY PASSING CARS WITH LIGHTS ON AND AT WORK WITH PEOPLE'S DIGITAL COMPUTERS AND KEYBOARDS, SEVERE MIGRAINES FROM POOR VISIONS. IT WAS ALSO REPORTED THAT PATIENT QUALITY OF LIFE HAS DRAMATICALLY CHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT WAS HAVING ISSUES WITH INTERMEDIATE, DISTANCE VISION NOT CLEAR, COULD NOT SEE FACE OF CHILD IN HER LAP, OR THE LICENSE PLATE ON CARS IN FRONT OF HER, LEFT EYE WAS WORSE THAN RIGHT EYE. SHE WAS HAVING HORRIBLE HALOS AND GLARE FROM LIGHTS AT NIGHT. NEXT POST-OP APPOINTMENT WAS SCHEDULED ON (B)(6) 2023. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE PATIENT SAW SURGEON ON (B)(6) 2023 AND WAS TOLD PATIENT VISION WAS 20/20. SURGEON TOLD PATIENT TO USE BRIGHTER LIGHT WHEN TRYING TO READ PAPERS AT WORK LIKE FLASHLIGHT USED IN OFFICE WHICH WORKED VERY WELL FOR HER. SURGEON INSTRUCTED HER TO STOP STEROID DROP. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

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

  MAUDE report 17583578 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT CARE COORDINATOR REPORTED THAT THE PATIENT HAD DIZZINESS AND DEPTH PERCEPTION PROBLEM FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION. THE PATIENT HAD TROUBLE DRIVING AS WELL. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS THAT THE PATIENT WAS NOT HAPPY WITH THE LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17352558 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AS THERE WAS NO PROBLEM TO PATIENT AFTER INTRAOCULAR LENS (IOL) REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Impairment

  MAUDE report 16724242 ↗
• 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 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. PATIENT 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 ASSOCIATED WI

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

  MAUDE report 15233481 ↗
• MalfunctionFeb 24, 2022Break; Break

  A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE OPTIC NEAR THE TRAILING HAPTIC WAS FOUND DAMAGED. IT WAS UNKNOWN WHEN THE LENS WAS DAMAGED. SURGERY WAS PERFORMED AND COMPLETED WITHOUT PRODUCT REPLACEMENT. THE LENS REMAINS IMPLANTED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13590289 ↗