Clareon CNWTT0 (UDI 00380652408158)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable · Class 3 · Implant
Quick summary
This Alcon Clareon toric lens is an implantable lens used in cataract surgery. The 41 reports mostly describe blurred vision, glare and halos, and lenses that broke, shifted out of position, or were removed and replaced, including no deaths and 22 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00380652408158), received between Jun 9, 2022 and Sep 18, 2026 — classified as 23 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Break” (5 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem17
- Break5
- Scratched Material4
- Device Dislodged or Dislocated3
- Material Split, Cut or Torn3
- Appropriate Device Problem Term/Code Not Available2
- Defective Device2
- Crack1
Patient problems
- Insufficient Information13
- Visual Disturbances12
- Blurred Vision11
- Visual Impairment9
- No Clinical Signs, Symptoms or Conditions8
- Diplopia/Double Vision3
- Halo3
- Dry Eye(s)1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
A non-healthcare professional reported that following a cataract extraction procedure with intraocular lens (IOL) implantation in the right eye, the patient experienced blurred vision, double vision, a sensation of heaviness, and bilateral ocular discomfort. The physician advised that the patient would likely adapt to the implanted lens and that the symptoms were expected to improve within approximately six months following surgery. However, the reported symptoms did not improve and the patient subsequently experienced significant difficulty reading. Approximately three months following the initial surgery, a laser procedure was performed to clean the lens; however, the intervention failed to resolve the issue.There are two Medical Device Reports associated with this patient. This report is for left eye.
Patient problems: Blurred Vision; Diplopia/Double Vision; Eye Irritation
MAUDE report 50818039 ↗MalfunctionSep 13, 2026Break
Patient problems: Insufficient Information
MAUDE report 50747087 ↗MalfunctionAug 10, 2026Material Split, Cut or Torn
A healthcare professional reported that during an intraocular lens (IOL) implant procedure, the lens optic broke. The lens was replaced with a new unspecified lens, which was then successfully implanted in the patient. No patient-related incidents occurred.Additional information has been requested and received stating that the lens was explanted during initial procedure. The procedure was completed on same day.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50191141 ↗MalfunctionMay 27, 2026Device Dislodged or Dislocated
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SECONDARY EXPLANT WAS PLANNED DUE TO PATIENT HAD EXPERIENCED GLARE, POOR VISION. CLINICAL REASON WAS IOL MIGRATION/ DECENTRATION PROGRESSIVE. LENS WAS PLANNED TO BE REPLACED WITH MONOFOCAL IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Visual Disturbances
MAUDE report 25302640 ↗InjuryMay 8, 2026Appropriate Device Problem Term/Code Not Available
A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PATIENT EXPERIENCED WITH DECREASED VISUAL ACUITY AND GLARE. THE LENS WAS EXPLANTED REPLACED WITH MONOFOCAL LENS IN SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 25125366 ↗MalfunctionApr 29, 2026Material Opacification; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD BLURRED VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS HAZY OPTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Blurred Vision
MAUDE report 25027439 ↗MalfunctionApr 27, 2026Break
A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) AS THE DOCTOR WAS IMPLANTING THE IOL, IT WAS DISCOVERED MIDWAY THROUGH THE PROCEDURE THAT ONE OF THE IOL HAPTICS HAD BROKEN. THERE WAS NO PATIENT CONTACT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND STATED THAT THE TRAILING HAPTIC WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001346 ↗MalfunctionApr 16, 2026Optical Decentration; Material Twisted/Bent
A NON HEALTHCARE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION THE IOL WAS DECENTERED DUE TO A DEFECT AT THE OPTIC HAPTIC JUNCTION. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE IOL WAS REMOVED AND REPLACED WITH ANOTHER IOL DURING THE INITIAL SURGERY. NO HARM WAS CAUSED EXCEPT THE LENS WAS DECENTERED IN THE EYE; THEREFORE, A NEW IOL WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896103 ↗MalfunctionDec 26, 2025Failure to Deliver; Failure to Deliver
A PHYSICIAN REPORTED WITH A DESCRIPTION THAT THE LENS DID NOT ADVANCE PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23896898 ↗InjuryDec 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DISLOCATED AND PROGRESSIVELY MOVED NASALLY. THE PATIENT EXPERIENCED BLURRED VISION AND SAW RINGS TO THE LATERAL ASPECT OF HIS VISION. IT APPEARED THAT THE CAPSULE WAS FIBROSING, THOUGH HIS PUPIL DID NOT DILATE ENOUGH TO ALLOW VISUALIZATION ON THAT DAY. THE PATIENT RETURNED TO THE OPERATING ROOM, WHERE A NON-COMPANY PUPIL EXPANSION RING WAS USED TO HOLD THE IRIS OPEN, INFLATE THE CAPSULE, AND ROTATE THE IMPLANT TO ENSURE STABILITY AND CENTRATION. THE PATIENT HAD PREVIOUSLY UNDERGONE PHACOEMULSIFICATION AND AN INTRAOCULAR LENS PROCEDURE BUT WAS DISSATISFIED WITH THE QUALITY OF VISUAL ACUITY AT BOTH DISTANCE AND NEAR IN THE AFFECTED EYE. HE WAS STRAINING TO SEE AND WAS UNABLE TO DRIVE, WATCH TV, OR READ. HE HAD MONOCULAR DIPLOPIA. DURING THE LENS REPOSITIONING PROCEDURE, COMPLICATIONS OCCURRED INCLUDING VITREOUS LOSS, AND AN ANTERIOR VITRECTOMY WAS PERFORMED. THE TEMPORAL HAPTIC OF THE INTRAOCULAR LENS WAS GRASPED, AND SCISSORS WERE USED TO CUT THE LENS IMPLANT OPTIC IN HALF. EACH HALF WAS DIALED OUT OF THE WOUND. A COMPANY POSTERIOR CHAMBER LENS IMPLANT WAS THEN INJECTED IN
Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Impairment; Vitreous Loss
MAUDE report 23728875 ↗MalfunctionOct 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BROKEN. THE LENS WAS EXPLANTED AND REPLACED WITH SAME MODEL SAME DIOPTER SAME COMPANY BACK UP LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23331415 ↗InjuryJul 13, 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE DIFFERENT LENS REQUIRED. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY WITHIN A MONTH AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22490812 ↗MalfunctionJul 8, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAPTIC WAS BROKEN AND IT WAS NOT USED. IT WAS STATED THAT, THE ISSUE WAS OBSERVED AFTER THE PRODUCT WAS OPENED. THERE WAS NO PATIENT CONTACT AND NO IMPACT. ADDITIONAL INFORMATION RECEIVED AND CONFIRMED THAT, THE FRACTURE IN THE RELEVANT HAPTIC WAS NOTICED DURING THE SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22440299 ↗InjuryJul 1, 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, THE PATIENT HAD BLURRY VISION, HEADACHE. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS UNEXPECTED REFRACTIVE ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Headache; Visual Impairment
MAUDE report 22370330 ↗InjuryJun 2, 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 HAD GLARE & HALOS. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS MECHANICAL COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT HAD GLARE AND HALOS WHICH CAUSED DIFFICULTY DRIVING AT NIGHT. THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS. THE PATIENT ISSUES RESOLVED POST IOL EXCHANGE.
Patient problems: Visual Disturbances
MAUDE report 22122148 ↗MalfunctionMay 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACK WAS FOUND IN THE LENS AND IT WAS EXCHANGED.
Patient problems: Insufficient Information
MAUDE report 22077489 ↗MalfunctionMay 21, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BROKEN HAPTIC WAS NOTICED. THE PATIENT WAS IN CONTACT WITH THE PRODUCT, BUT SURGERY WAS COMPETED SUCCESSFULLY WITH ANOTHER SAME DIOPTER LENS ON SAME DAY WITHOUT ANY IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22063390 ↗MalfunctionApr 21, 2025Inaccurate Delivery; Inaccurate Delivery
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS LOADED INTO THE CARTRIDGE THE CORRECT ORIENTATION. THE SURGEON BELIEVED THE IOL ROTATED IN CARTRIDGE AND EMERGED UPSIDE DOWN IN THE EYE. THE SURGEON BELIEVES THE IOL ROTATED IN CARTRIDGE AND EMERGED UPSIDE DOWN IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21875156 ↗InjuryMar 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A FACILITY REPRESENTATIVE REPORTED THAT THE PATIENT WAS DISSATISFIED WITH THE IMPLANT. THE LENS WAS EXCHANGED WITH AN UNSPECIFIED MONOFOCAL IOL AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21677759 ↗InjuryMar 19, 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, THE PATIENT EXPERIENCED WAXY VISION AND WAS NOT ACCUSTOMED TO HIS/HER VISION AND WAS DISSATISFIED. THE IOL WAS EXCHANGED FOR MONOFOCAL IOL 1 MONTH 3 WEEKS 6 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 21639591 ↗MalfunctionFeb 7, 2025Break; Break
A NURSE REPORTED THAT BEFORE THE INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 21331839 ↗MalfunctionJan 3, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SCRATCH AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21066125 ↗InjuryDec 27, 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,LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED UNABLE TO TOLERATE DYSPHOTOPSIA .THE IOL WAS REPLACED WITH MONOFOCAL IOL APPROXIMATELY TWO MONTH AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 21027190 ↗InjuryDec 4, 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE. THE CLINICAL REASON WAS REPORTED TO BE REFRACTIVE SURPRISE.THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY FIVE MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 20843213 ↗MalfunctionOct 25, 2024Crack; Crack
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE,THE CRACK WAS NOTICED ON THE OPTIC PART OF IOL. LENS WAS EXPLANTED AT INITIAL PROCEDURE.THE IOL WAS REPLACED WITH UNSPECIFIED LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20531152 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS18 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.