Clareon CNWTT0 (UDI 00380652408134)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable · Class 3 · Implant
Quick summary
This Alcon Clareon CNWTT0 is a foldable intraocular lens implanted in cataract surgery. The 31 reports mostly describe vision problems after implantation, such as blurred vision, halos, and a shift in focus, which in several cases led to the lens being removed and replaced in a second surgery. Other reports describe the lens breaking, cracking, or not unfolding properly during surgery. There were 14 injuries and no deaths. 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
- 32
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00380652408134), received between Apr 8, 2022 and Sep 24, 2026 — classified as 15 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Break” (4 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 Problem10
- Break4
- Material Split, Cut or Torn3
- Scratched Material3
- Crack2
- Failure to Unfold or Unwrap2
- Material Twisted/Bent2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Insufficient Information13
- Blurred Vision8
- No Clinical Signs, Symptoms or Conditions6
- Visual Disturbances4
- Visual Impairment4
- Corneal Edema1
- Halo1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
A healthcare professional reported about a power change following cataract surgery with implantation of an intraocular lens (IOL). The lens was explanted with reason mentioned as simple prescription change with no other reason provided.
Patient problems: Visual Impairment
MAUDE report 50883847 ↗InjuryAug 5, 2026Appropriate Device Problem Term/Code Not Available
A health care professional reported that during an intraocular lens (IOL) implant procedure, Exchange due to patient's decreased vision surgery was performed and exchanged to Eyhance. Additional information has been requested.
Patient problems: Blurred Vision
MAUDE report 50136866 ↗InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD POOR VISION. CLINICAL REASON BEING MENTIONED AS MYOPIC SHIFT. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED BY STATING THE PATIENT MISSED TARGET. THERE WAS NO FURTHER IMPACT TO THE PATIENT.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 25778711 ↗MalfunctionJun 10, 2026Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE IT WAS BEING INSERTED HAPTIC WAS BROKEN. THE PROCEDURE WAS COMPLETED ON SAME DAY. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 25458723 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT WAS DISSATISFIED WITH QUALITY OF VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH COMPANY SPECIFIC LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS UNHAPPY WITH QUALITY OF VISION. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION WAS RECEIVED.
Patient problems: Blurred Vision
MAUDE report 25348119 ↗InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT HAD EXPERIENCED HALOS CONTINUOUSLY AND HAD POOR DISTANCE VISION. THEREFORE, THE LENS WAS EXPLANTED AND REPLACED WITH UNSPECIFIED MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MENTIONED AS INTOLERANCE TO HALOS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Visual Disturbances
MAUDE report 25272673 ↗MalfunctionMar 16, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE EDGE OF THE IOL APPEARED STRETCHED. THE EVENT OCCURRED IN THE MIDDLE OF THE SURGERY. A LENS DEFECT WAS IDENTIFIED DURING THE LOADING PROCESS.
Patient problems: Insufficient Information
MAUDE report 24603235 ↗MalfunctionFeb 26, 2026Break; Optical Decentration
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACK WAS FOUND IN THE LEADING HAPTIC AND THE CENTER PORTION WAS SHIFTED. THE LENS REMAINS IN THE PATIENT EYE AND THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE CENTRAL PORTION OF THE IOL IS DECENTERED. THE PATIENT VISUAL ACUITY WAS GOOD AND THE PATIENT WILL BE FOLLOWED UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24453558 ↗MalfunctionFeb 9, 2026Material Split, Cut or Torn
ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE LENS HAD BEEN REPLACED ON THE SAME DAY, AND THE SURGERY HAD BEEN COMPLETED WITHOUT HARM TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 24290615 ↗MalfunctionFeb 2, 2026Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAS A CRACK IN THE OPTICS AFFECTING THE CENTER OF THE LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY AND WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24234796 ↗InjuryDec 31, 2025Scratched Material; Scratched Material
A NURSE REPORTED WITH A DESCRIPTION, DUE TO AN OPTIC SCRATCH IN THE INITIAL PROCEDURE PATIENT EXPERIENCED SEVERE GLARE IN DISTANT VISION POST-OPERATIVELY. SO, THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 DAY FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THERE WAS SLIGHT CORNEAL SWELLING BUT THE REFRACTIVE VALUE WAS NORMAL.
Patient problems: Corneal Edema; Visual Disturbances
MAUDE report 23932685 ↗MalfunctionNov 11, 2025Failure to Unfold or Unwrap; Material Twisted/Bent; Failure to Unfold or Unwrap; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING LOADING PROCESS OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC OF THE INTRAOCULAR LENS FAILED TO UNFOLD. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522658 ↗MalfunctionOct 30, 2025Break; Break
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC BROKE UPON INSERTION. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE LENS WITH ANOTHER LENS DURING THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 23424639 ↗MalfunctionSep 18, 2025Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS DISCOVERED ON THE LENS AT THE TIME OF INSERTION. THE LENS WAS CUT OUT AND REPLACED WITH NEW LENS. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085323 ↗InjuryMay 29, 2025Adverse 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, THE PATIENT EXPERIENCED HALOS. WHEN READING ON CELL PHONE, IMAGES ARE ANGLED, BLURRED. THE IOL WAS EXCHANGED FOR ANOTHER MODEL OF COMPANY LENS 4 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DYSPHOTOPSIA RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 22105068 ↗MalfunctionMay 20, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. WHILE THE DOCTOR WAS INJECTING LENS INTO THE EYE, IT WAS OBSERVED THAT THE TRAILING HAPTIC WAS BROKEN. THE LENS WAS REMOVED FROM THE EYE DURING THE SAME PROCEDURE. NO FURTHER INFORMATION EXPECTED AS CUSTOMER WAS UNWILLING TO PROVIDE.
Patient problems: Insufficient Information
MAUDE report 22054369 ↗MalfunctionApr 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CRACK WAS OBSERVED ON THE OPTIC AFTER IMPLANTATION. LENS WAS EXPLANTED IN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21750216 ↗MalfunctionFeb 24, 2025Material Twisted/Bent; Material Twisted/Bent
A NURSE REPORTED DURING SURGERY LENS WAS DEFECTIVE IN THE PACKAGING, BUT WE DID NOT NOTICE IT UNTIL THE IMPLANTATION STAGE. THE SURGEON ONLY DETECTED THE ISSUE WHEN THE LENS WAS ALREADY IN THE PATIENT'S EYE. AS A RESULT, WE HAD TO REMOVE IT FROM THE PATIENT¿S EYE BY SPLITTING AND EXTRACTED THE LENS AND THEN IMPLANTED A NEW CORRESPONDING ONE DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATED THAT THE LEADING HAPTIC BULGE ON THE EDGE OF THE LENS AND IT WAS INSIDE THE EYE AND THE DOCTOR SAW WHAT LENS WAS DEFECTIVE. THE DOCTOR DECIDED TO CUT THE LENS AND PULL OUT. WE HAD ANOTHER LENS IN THE HOSPITAL WAS USED. IT WAS LITTLE BIT LONGER THAN USUAL.
Patient problems: Insufficient Information
MAUDE report 21445400 ↗MalfunctionFeb 7, 2025Dent in Material; Dent in Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A CREASE ACROSS THE CENTER. THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED USING THE BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21331944 ↗MalfunctionDec 4, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THE PROCEDURE COMPLETED ON THE SAME DAY AND EXPLANTED INTRAOCULAR LENS DURING INITIAL PROCEDURE AFTER IMPLANTATION.
Patient problems: Insufficient Information
MAUDE report 20840658 ↗InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT HAD TROUBLE WITH DISTANCE AND NEAR WITH RIGHT EYE. THE LENS WAS SUBSEQUENTLY EXPLANTED IN THE SECONDARY PROCEDURE.
Patient problems: Blurred Vision
MAUDE report 20755414 ↗MalfunctionAug 13, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED, THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE LENS GOT STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19973829 ↗InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD GLARE AND HALOS. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Halo; Visual Disturbances
MAUDE report 19919245 ↗InjuryMay 8, 2024Crack; Crack
A HEALTH CARE PROFESSIONAL REPORTED A CRACKED OPTIC UPON IMPLANTATION. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE LENS WAS REMOVED IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19267033 ↗InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE CONDITION AFTER THE REPLACEMENT OF IOL WAS GOOD.
Patient problems: Blurred Vision
MAUDE report 19220141 ↗
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 OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 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.