Clareon CNWTT0 (UDI 00380652408165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00380652408165), received between Mar 12, 2022 and Sep 26, 2026 — classified as 18 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2026Failure to Advance; Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906904 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  A healthcare professional reported that, following intraocular lens implantation surgery, the patient experienced decreased visual acuity. Subsequently the lens was removed and replaced with an unspecified advanced technology intraocular lens (ATIOL) in a secondary procedure. Additional information has been requested but is not available at the time of this report.

  Patient problems: Blurred Vision

  MAUDE report 50194807 ↗
• MalfunctionMar 16, 2026Break

  A PHYSICIAN REPORTED THAT THE LENS WAS OPENED ON THE TABLE, FOLDED IN THE CARTRIDGE, AND BEFORE PLACING IT INTO THE EYE, IT WAS OBSERVED THAT THE HAPTIC (THE LEG OF THE LENS) WAS BROKEN AND IT WAS NOT APPLIED ON THE PATIENT. SURGERY WAS COMPLETED ON THE SAME DAY BY IMPLANTING ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605645 ↗
• InjuryMar 7, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. CLINICAL REASON BEING MENTIONED AS PSEUDOPHAKIA RIGHT EYE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Blurred Vision

  MAUDE report 24539870 ↗
• InjuryMar 4, 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. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 18 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS ASTIGMATISM WORSE. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE IOL EXCHANGE OCCURRED BECAUSE THE PATIENT HAD BEEN GIVEN A NON-TORIC COMPANY LENS INSTEAD OF A TORIC LENS. THE PATIENT HAD DECIDED TO GO WITH THE COMPANY'S TORIC LENS BECAUSE SHE FELT IT SUITED HER NEEDS. THE DOCTOR BELIEVED SHE HAD NEEDED A TORIC LENS, AS PATIENT'S ASTIGMATISM HAD BEEN MADE WORSE WITH THE COMPANY NON-TORIC LENS. THE PATIENT WAS SEEING WELL AND DOING WELL OVERALL WITH THE NEW LENS.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24505329 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LEFT EYE HAD HALOS AND IT WAS LIKE LOOKING THROUGH RAIN IN THE MIDDLE OF THE LENS. PATIENT SPOKE WITH SURGEON AND SUGGESTED TO WEAR YELLOW TINTED GLASSES WITH A SMALL PRESCRIPTION. PATIENT SAID IT DID NOT HELP. PATIENT CAN LOOK UP OR DOWN AND SEE CLEARLY BUT STRAIGHT AHEAD IN BOTH EYES ARE SMUDGED. PATIENT COULD NOT SEE TO DRIVE AT NIGHT, IF THERE WERE FLASHING LIGHTS LIKE POLICE LIGHTS PATIENT HAS TO PULL OVER UNTIL GONE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR RIGHT EYE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 24377441 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LEFT EYE HAD HALOS AND IT WAS LIKE LOOKING THROUGH RAIN IN THE MIDDLE OF THE LENS. PATIENT SPOKE WITH SURGEON AND SUGGESTED TO WEAR YELLOW TINTED GLASSES WITH A SMALL PRESCRIPTION. PATIENT SAID IT DID NOT HELP. PATIENT CAN LOOK UP OR DOWN AND SEE CLEARLY BUT STRAIGHT AHEAD IN BOTH EYES ARE SMUDGED. PATIENT COULD NOT SEE TO DRIVE AT NIGHT, IF THERE WERE FLASHING LIGHTS LIKE POLICE LIGHTS PATIENT HAS TO PULL OVER UNTIL GONE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24329605 ↗
• InjuryJan 23, 2026Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A VISITING SURGEON FROM THE KALUGA BRANCH PERFORMED PHACOEMULSIFICATION AND IMPLANTATION OF AN INTRAOCULAR LENS. AFTER THE SURGERY, COMPLICATIONS BEGAN. THE DIAGNOSTIC AND TREATMENT DEPARTMENT WAS CLOSED, SO THE SCHEDULED POSTOPERATIVE EXAMINATION DID NOT TAKE PLACE. AFTER CONSULTING OPHTHALMOLOGISTS, THE PATIENT WAS UNABLE TO EXPLAIN WHICH LENS HAD BEEN IMPLANTED. THE DOCTORS STATED THAT THE DISCHARGE SUMMARY MUST INDICATE WHICH LENS WAS USED, THE METHOD OF IMPLANTATION, AND MUST INCLUDE A STICKER AND AN IDENTIFICATION CARD FROM THE PACKAGE. THE CLINIC SENT THE IOL NAME AND SERIAL NUMBER BY EMAIL, BUT NO DOCUMENTS, PHOTOS, OR STICKERS CONFIRMING THE ORIGIN OF THE IOL WERE PROVIDED. ANTERIOR SEGMENT TOMOGRAPHY REVEALED THE CAUSE OF THE VISUAL DETERIORATION, AN 8.1-DEGREE TILT RELATIVE TO THE HORIZONTAL PLANE OF THE EYE. THERE WAS A GAP WITH THE POSTERIOR PART OF THE CAPSULAR BAG CAVITY AND PROGRESSION OF SECONDARY CATARACT IN THE OPERATED LEFT EYE. THE PATIENT EXPERIENCED TEARING AND FOREIGN BODY SENSATION, A TORN FOVEAL MACULAR, AND ROTATION OF THE OPTIC AND THE ENTIRE LENS BY 35 DEGREES

  Patient problems: Foreign Body Sensation in Eye; Posterior Capsule Opacification; Retinal Tear; Visual Impairment

  MAUDE report 24172929 ↗
• MalfunctionDec 12, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED DURING CATARACT REMOVAL AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS OBSERVED A DAMAGED POSTERIOR HAPTIC OF THE LENS DURING IMPLANTATION AFTER TAKING IT OUT FROM THE PLASTIC PACKAGING WITHOUT IMPACT ON PATIENT. THE PROCEDURE COMPLETED WAS COMPLETED ON SAME WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791188 ↗
• MalfunctionNov 26, 2025Device Difficult to Setup or Prepare; Material Deformation; Device Difficult to Setup or Prepare; Material Deformation

  A NONHEALTHCARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED DURING LOADING. IT WAS NOT IMPLANTED. THE EVENT OCCURRED DURING IOL IMPLANTATION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23654464 ↗
• MalfunctionOct 31, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED THAT, DURING THE OPERATION, THE LENS WAS OPENED DURING THE IMPLANTATION PHASE. AFTER BEING PLACED INTO THE COMPANY CARTRIDGE AND INJECTOR AND DELIVERED INTO THE EYE, IT WAS OBSERVED THAT THE POSTERIOR HAPTIC WAS BROKEN. THE LENS WAS REMOVED AND THE OPERATION WAS COMPLETED USING ANOTHER LENS WITH THE SAME DIOPTER. THERE IS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434710 ↗
• MalfunctionOct 20, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF ¿OLD LENS IN THE PACKAGING¿. HAPTIC DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23344511 ↗
• InjuryAug 21, 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, AFTER ONLY 7-8 DAYS PATIENT BEGAN TO SEE WELL TO VERY WELL BOTH UP CLOSE AND AT A DISTANCE. BUT AT INTERMEDIATE DISTANCES VISION WAS NOT GOOD AND ONLY SLIGHTLY IMPROVED. FROM DAY 10-11 PATIENT STARTED TO SEE MORE POORLY OR BLURRIER AND SEES THE TEXT ON SCREENS (PHONE OR TELEVISION) WITH A WHITE-GRAY OUTLINE AROUND THE WORDS. THE NEAR VISION, WHICH HAD BECOME ALMOST PERFECT AT FIRST WAS NOW BLURRY THAN A WEEK AGO. PATIENT ALSO CAN NO LONGER SEE CLEARLY AT A DISTANCE OF 3 TO 4 METERS AND AT A GREATER DISTANCE EVERYTHING WAS BLURRY, IT WAS BETTER IN THE FIRST 10 DAYS. WHEN LOOKING AT THE COMPUTER FROM 60-70 CM, WHICH WAS VERY BLURRY AND THE LETTERS ARE UNCLEAR COMPARED TO OTHER DISTANCES AND THIS ASPECT WAS EXTREMELY IMPORTANT TO THE PATIENT AS IT INVOLVES COMPUTER AND THE PATIENT WORKS 7-8 HOURS A DAY. PATIENT STARTED TO SEE HALO AT NIGHT AROUND THE LIGHTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22860384 ↗
• InjuryAug 20, 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 BLURRY VISION AT DISTANCE AND NEAR AND CANNOT ADJUST TO HALOS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 12 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS REDUCE HALOS AND POSSIBLY IMPROVE VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22853137 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED BY STATING, PATIENT WAS DISSATISFIED WITH DISTANCE ACUITY AND NIGHT TIME AND EXPERIENCED DIFFRACTIVE OPTIC IN SPITE OF GOOD REFRACTIVE OUTCOME, GLARE AND HALOES.

  Patient problems: Visual Impairment

  MAUDE report 22411168 ↗
• MalfunctionMay 26, 2025Break; Break

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT THE LENS IMPLANTATION STAGE DESPITE USING THE COMPANY LENS INJECTOR AND CARTRIDGE, THE HAPTIC PART OF THE LENS WAS BROKEN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084650 ↗
• MalfunctionMay 16, 2025Failure to Deliver; Dent in Material; Failure to Deliver; Dent in Material

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS CHIPPED ON THE MD PERIPHERAL CENTRAL RINGS AND THE PHYSICIAN COULDN'T INSERT THE LENS WITH A 2.2 INCISION AND IT FELT STUCK IN THE COMPANY INJECTOR. SO, THEY REMOVED AND NOTICED THAT THE LENS WAS CHIPPED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH UNSPECIFIED REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22036873 ↗
• InjuryApr 25, 2025Material Deformation; Material Deformation

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED. THE LENS WAS EXPLANTED AND IMPLANTED WITH BACKUP LENS. DURING EXPLANT THE LENS HAPTIC WAS TORN OFF. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE INCISION WAS WIDENED DURING EXPLANTATION OF LENS AND A NEW LENS OF THE SAME DIOPTER HAD TO BE IMPLANTED. PATIENT EXPERIENCED POST-OPERATIVE CORNEAL SWELLING AND DECREASE IN VISUAL ACUITY.

  Patient problems: Blurred Vision; Corneal Edema

  MAUDE report 21911334 ↗
• MalfunctionMar 6, 2025Product Quality Problem; Product Quality Problem

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ACCORDING TO THE SURGEON DURING IMPLANTATION THROUGH THE CARTRIDGE AND WHEN USING THE INJECTOR THE LENS WAS DEFORMED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO PATIENT CONTACT AND NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537632 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT CANNOT SEE TO DRIVE AT NIGHT BECAUSE THE HEADLIGHTS ALL LOOK LIKE FIREWORKS, HER CHRISTMAS TREE LOOKED LIKE FIREWORKS. ALL LIGHTS HAD A TERRIBLE GLARE OR HALO. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE PATIENT EXPERIENCED DECREASED VISION FROM GLARE AND HALOS, MORE SIGNIFICANTLY AT NIGHT WHILE DRIVING DUE TO WHICH SHE WAS UNABLE TO DRIVE. ADDITIONALLY, AN ALPHA-ADRENERGIC AGONIST DRUG HAS BEEN PRESCRIBED TO THE PATIENT TO CAUSE MIOSIS OF THE PUPIL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, THE PATIENT'S SYMPTOMS WAS ONGOING. SHE WAS TOLD BY HER SURGEON THAT, HALOS AND GLARE ARE SIDE EFFECT OF THE LENS TECHNOLOGY, AND MOST PEOPLE CAN ADAPT OVER TIME. SHE HAS TRIED ALPHA-ADRENERGIC AGONIST DRUG FOR NIGHT DRIVING BUT HAD NO IMPROVEMENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21445672 ↗
• MalfunctionFeb 20, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF HAPTIC DEFECT WAS NOTICED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING DURING A FEMTOSECOND LASER CATARACT SURGERY (FLC) AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS TORN WITH NO PATIENT CONTACT AND NO PATIENT HARM. THE PLANNED PROCEDURE WAS COMPLETED USING SAME LENS THE PRODUCT NOT REUSED. CURRENT PATIENT CONDITION WAS SATISFACTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21418590 ↗
• MalfunctionJan 23, 2025Break; Break

  A PHYSICIAN REPORTED THAT, THE LENS CAME OUT WITH BROKEN HAPTICS. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, THE HAPTIC BROKE WHEN MOUNTING THE LENS ON THE CARTRIDGE. THE SURGERY WAS COMPLETED USING ANOTHER LENS OF SAME MODEL.

  Patient problems: Insufficient Information

  MAUDE report 21216767 ↗
• MalfunctionJan 7, 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 21090886 ↗
• MalfunctionDec 10, 2024Break; Break

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION HAPTIC OF THE LENS CAME OFF. THE LENS HAD TO BE CHANGED; THE PATIENT WAS NOT INJURED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT DURING SURGERY, DURING LENS IMPLANTATION IN THE ANTERIOR CHAMBER NOTICED THAT HAPTIC OF THE LENS CAME OFF AND THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AND EXCHANGED FOR UNSPECIFIED LENS DURING INITIAL PROCEDURE. THE PATIENT CONDITION IS SATISFACTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20890678 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED, THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE PATIENT, EXPERIENCED WITH WAXY VISION AND COMPLAINED OF VISUAL DISCOMFORT. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 23 DAYS, FOLLOWING THE INITIAL PROCEDURE. THE IOL WAS REPLACED WITH A MONOFOCAL ONE AND THE VISUAL ACUITY IMPROVED, THERE WAS NO HEALTH DAMAGE TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. FROM SURGEON AND STATED, THAT PATIENT'S CONDITION WAS GOOD, AFTER THE REPLACEMENT TO THE MONOFOCAL IOL. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.

  Patient problems: Blurred Vision

  MAUDE report 20083403 ↗