Clareon CNWTT0 (UDI 00380652408196)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00380652408196), received between Jul 15, 2022 and Apr 29, 2026 — classified as 14 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Break; Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE IS DIFFICULTY IN ADVANCING IOL IN THE CARTRIDGE, HENCE HAPTICS GOT BROKEN. THERE WAS NO PATIENT CONTACT AND PROCEDURE WAS COMPLETED ON SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034645 ↗
• InjuryJan 9, 2026Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE IMPLANTING THE IOL, A KINK WAS DISCOVERED IN THE LENS HAPTIC. AS A RESULT, EXPLANTATION HAD TO BE PERFORMED DURING THE SAME PROCEDURE, AND A NEW IOL WAS IMPLANTED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THE PATIENT'S VISION WAS DETERIORATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; Visual Impairment

  MAUDE report 24022573 ↗
• MalfunctionOct 31, 2025Break; Scratched Material; Break; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DAMAGE BY COMPANY HANDPIECE INJECTOR. HAPTIC WAS BROKEN OR TORN OR MISSING. SCRATCH OR MARK ON OPTIC OR BLEMISH OR INDENTATION OR SCUFF MARK OR SCORE MARK ON OPTIC WAS OBSERVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23434188 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  A NURSE REPORTED THAT DURING DELIVERY OF THE LENS INTO THE EYE, IT WAS OBSERVED THAT THE CARTRIDGE INJECTOR DELIVERED THE LENS NOT FROM THE TIP BUT BY TEARING THE LOWER PART OF THE CARTRIDGE. IT WAS ALSO OBSERVED THAT THE TRAILING HAPTIC WAS CAUGHT IN THE TEAR FORMED AT THE BOTTOM OF THE CARTRIDGE AND IT DID NOT DELIVER THE LENS FROM THE TIP OF THE INJECTOR. THE LENS WAS REMOVED FROM THE PATIENT'S EYE DURING INITIAL PROCEDURE AND THE OPERATION CONTINUED AND COMPLETED ON THE SAME DAY WITH A DIFFERENT UNSPECIFIED LENS WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279261 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS IMPLANTATION AND EMMETROPIA, THE PATIENT RECEIVED VISION OF 0.3 AND 0.4 IN THE DISTANCE. THE PATIENT CORRECTS AT 0.5 AND WITH CORRECTION VISUAL ACUITY IN BOTH EYES IS 1.0, THE SURGEON HAS PERFORMED ADDITIONAL CORRECTION WITH AN EXCIMER LASER.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22963356 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT, ONE MONTH AFTER THE INTRAOCULAR LENS IMPLANTATION SURGERY, THE UNCORRECTED DISTANCE VISUAL ACUITY WAS 0.3 IN THE LEFT EYE. WITH A CORRECTION OF 0.5 DIOPTERS, THE VISUAL ACUITY REACHED 1.0. THE SURGEON HAD PERFORMED LASER ENHANCEMENT TREATMENT AND THE PATIENT CONDITION WAS SATISFACTORY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Visual Impairment

  MAUDE report 22932302 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD SMART LENSES INSERTED IN BOTH EYES. ALTHOUGH PATIENT HAD GONE TO THE DOCTOR MANY TIMES AND CHANGED THE MEDICATIONS, HAD DIFFICULTY OPENING AND CLOSING EYES DUE TO THE BURNING, STINGING IN EYES AND EXCESSIVE BURRS AT THE BOTTOM OF EYELASHES. PATIENT WANTED TO IMPROVE QUALITY OF LIFE AS UNEASINESS INCREASED WITH THIS SURGERY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. (2 OF 2). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Irritation; Unspecified Eye / Vision Problem

  MAUDE report 22105782 ↗
• MalfunctionMay 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS OBSERVED TO BE BROKEN WHEN IMPLANTED. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND REPLACED WITH UNSPECIFIED LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968293 ↗
• MalfunctionApr 30, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS LOADED INTO INJECTOR AS USUAL, INSERTED INTO THE BAG, AND UPON OPENING THE BAG, THE HAPTICS BROKE. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21932988 ↗
• MalfunctionMar 6, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS FAULTY WHICH HAD A DAMAGED HAPTIC. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE TRAILING HAPTIC WAS INVOLVED. THE LEADING HAPTIC OF THE INTRAOCULAR LENS WAS IN PATIENTS EYE HOWEVER THE TRAILING HAPTIC WAS NOT. LENS WAS REMOVED AT THE TIME OF INSERTION AND HAD NOT COMPLETELY PASSED INTO THE EYE WHEN NOTICED THE DEFECT IN THE HAPTIC. THE PROCEDURE WAS COMPLETED WITH THE BACK UP IOL AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534021 ↗
• MalfunctionMar 5, 2025Break; Break

  HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF HAPTIC WAS NOT IN CONDITION WHEN HE WAS TRYING TO IMPLANT THE LENS, AND HENCE HE CHANGED THE LENS TO NEW ONE AND COMPLETED THE SURGERY. ADDITIONAL INFORMATION STATED THAT THE LENS ENTERED THEN WAS REMOVED AND REPLACED WITH ANOTHER SAME LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21524307 ↗
• MalfunctionMar 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTED A SPLIT BETWEEN OPTIC AND HAPTIC. LENS WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED WITH NEW LENS WITH NO ISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21514360 ↗
• MalfunctionMar 3, 2025Break; Break

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAPTIC BROKE OFF. ADDITIONAL INFORMATION WAS RECEIVED LENS WAS IMPLANTED. AFTER IMPLANTING DOCTOR NOTICED HAPTIC LOOKED BROKEN AT THE OPTIC HAPTIC JUNCTION. HE STATED THIS WOULD HAVE BEEN DIFFICULT TO DO DURING THE LOADING PROCESS AND THINKS IT WAS LIKE THIS IN THE PACKAGE BUT WAS UNSURE.

  Patient problems: Insufficient Information

  MAUDE report 21505809 ↗
• InjuryJan 10, 2025Adverse 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 HALOS, STARBURSTS DURING DAY. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 21123144 ↗
• MalfunctionJan 9, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN AND LENS WAS DAMAGED BY THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21111646 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED, PATIENT VISION CONTINUES TO GET WORSE AND HAVE AN APPOINTMENT WITH THE SURGEON, BUT ITS STILL A COUPLE OF WEEKS AWAY AND WILL BRING THIS UP WITH HER.

  Patient problems: Visual Impairment

  MAUDE report 20224646 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CONSUMER'S DOCTOR REPORTED THAT THE CONSUMER (PATIENT) HAD BEEN VERY UNHAPPY WITH HIS VISION QUALITY FROM THE BEGINNING, DESCRIBING GLARE THAT PREVENTS HIM FROM DRIVING AT NIGHT, GENERAL DARKENING OF HIS VISION AND BLUR AT ALL DISTANCES. HE HAD A REFRACTION WITH A MILD RX NOTED, WHICH SEEMED INSUFFICIENT TO EXPLAIN THE SIGNIFICANCE OF HIS COMPLAINTS. HIS EXAM WAS UNREMARKABLE, WITH WELL CENTERED INTRAOCULAR LENS (IOL) AND NO OTHER PATHOLOGY OF SIGNIFICANCE. ACCORDING TO THE DOCTOR'S ASSESSMENT, HE SIMPLY IS NOT TOLERATING THE MULTIFOCAL OPTICS DESIGN, AND THEY ARE NOW DISCUSSING THE OPTION OF IOL EXCHANGE FOR HIM. THE DOCTOR REPORTS THAT THERE IS SIMPLY NOTHING ABOUT THE SURGERY OR CURRENT EXAM THAT WOULD RELATE TO HIS POSTOPERATIVE STRUGGLES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Visual Impairment

  MAUDE report 20224041 ↗
• InjuryApr 11, 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 HAD DIFFICULTY READING STREET SIGNS, COMPUTER SCREEN HAZY, ALWAYS SEES HALOS, SEVERITY WORSENING, LIGHT SENSITIVITY. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS MODEL APPROXIMATELY 4 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS BLURRED VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 19086104 ↗
• MalfunctionApr 1, 2024Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING SURGERY, THAT AFTER REMOVAL OF THE VISCOELASTIC BY IA, A 0.5 MM SCRATCH WAS FOUND NEAR THE CENTER OF THE IOL OPTIC DURING CENTERING. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THE SAMPLE WAS NOT AVAILABLE AS IT STILL REMAINS IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19010158 ↗
• MalfunctionMar 12, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT THEY NOTICED A DEFECT/SCRATCH ON THE LENS IN THE UPPER LEFT CORNER. DOCTOR NOTICED THE MARK AND POINTED IT OUT. HE DID NOT EXPLANT THE LENS AS IT WAS IN THE PERIPHERY AND HE DID NOT THINK IT WOULD IMPACT THE PATIENTS VISION. THE SCRUB TECH WAS TRAINED PROPERLY AND FOLLOWED THE PROPER STEPS WHEN SHE LOADED THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18886455 ↗
• MalfunctionJan 9, 2024Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT PLUNGER TRAVELLED OVER THE TOP OF THE IOL MEANING THE LENS DID NOT ADVANCE FORWARDS AND WAS DAMAGED. THE IOL WAS NOT IMPLANTED AND SURGERY WAS COMPLETED WITH A BACK UP IOL WITHOUT INCIDENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18473784 ↗
• InjuryNov 15, 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 HAD HALOS AND GLARE, AND DO NOT DRIVE AT NIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT PURCHASED SOME DRIVING GLASSES AT WAL-MART WHICH HELPED A LITTLE BIT. SHE HAS TAKEN MEDICATION FOR INVOLUNTARY DYSKINESIA FOR YEARS AND SINCE HAVING THE SURGERY SHE WAS NOT HAVING THE INVOLUNTARY MOVEMENTS ANYMORE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18140924 ↗
• InjuryNov 15, 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 HAD HALOS AND GLARE, AND DO NOT DRIVE AT NIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT PURCHASED SOME DRIVING GLASSES AT WAL-MART WHICH HELPED A LITTLE BIT. SHE HAS TAKEN MEDICATION FOR INVOLUNTARY DYSKINESIA FOR YEARS AND SINCE HAVING THE SURGERY SHE WAS NOT HAVING THE INVOLUNTARY MOVEMENTS ANYMORE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18140916 ↗
• InjuryNov 3, 2023Adverse 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 HALOS AT NIGHTTIME MAKING IT HARD TO DRIVE AT NIGHT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED WITH SERIAL NUMBER AND PHYSICIAN TOLD SYMPTOMS WOULD GET BETTER,PATIENT EXPERIENCED BLURRY DISTANCE AND NEAR VISION AND LIGHT SENSITIVITY.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 18065728 ↗
• InjuryOct 31, 2023Adverse 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 HALOS AT NIGHTTIME MAKING IT HARD TO DRIVE AT NIGHT. ADDITIONAL INFORMATION HAS BEEN RECEIVED WITH SERIAL NUMBER AND PHYSICIAN SAID SYMPTOMS WOULD GET BETTER. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT PATIENT HAVING BLURRY DISTANCE AND NEAR VISION AND LIGHT SENSITIVITY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 18037583 ↗