Clareon CNWTT0 (UDI 00380652408127)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Clareon multifocal intraocular lens is an implant used in cataract surgery. The 24 reports mostly describe blurred or disturbed vision, along with lenses tearing, bending, shifting out of position, or being replaced or removed. They include 17 injuries and no deaths; no recalls name this device. Reports fell from 8 in the previous 12 months to 2 in the latest 12 months.
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
- 24
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00380652408127), received between Oct 11, 2022 and Feb 13, 2026 — classified as 17 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem14
- Break3
- Optical Decentration2
- Defective Device1
- Device Dislodged or Dislocated1
- Failure to Advance1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
Patient problems
- Insufficient Information9
- Visual Disturbances7
- Blurred Vision6
- No Clinical Signs, Symptoms or Conditions4
- Visual Impairment4
- Halo2
- Intraocular Pressure Increased2
- Retinal Tear2
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS POST OPERATIVE AT DAY 1, THE PATIENT EXPERIENCED ELEVATED INTRAOCULAR PRESSURE (IOP). THE PATIENT WAS TREATED WITH CARBONIC ANHYDRASE INHIBITOR AND BETA-ADRENERGIC BLOCKER WHICH WAS STARTED FROM (B)(6) 2025 AND STOPPED ON (B)(6) 2025. THE PATIENT¿S SYMPTOMS WERE RECOVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Intraocular Pressure Increased
MAUDE report 24333369 ↗InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS GETTING HEADACHES EVERY DAY FROM ANY TYPE OF LIGHTING. THE PATIENT EXPERIENCED HUGE HALOS AND STARBURSTS AROUND LIGHTS AT NIGHT AND HAZINESS AROUND LIGHTS DURING THE DAY. USING A COMPUTER OR PHONE FOR ANY LENGTH OF TIME WAS HURTING THE PATIENT¿S EYES. THE PATIENT WAS INITIALLY TOLD TO WAIT. THE DOCTOR THEN TRIED EYE DROPS, WHICH BURNED TERRIBLY WHEN USED. THE PATIENT REPORTED THE EYE DROPS MADE EVERYTHING DARK AND MADE DRIVING AT NIGHT EVEN MORE DIFFICULT. THE DOCTOR ALSO SUGGESTED TRYING AR YELLOW LENSES, WHICH TURNED THE HALOS YELLOW. THE PATIENT STATED THEY COULD NOT SEE ANY CLEARER AND WOULD HAVE PREFERRED TO STAY WITH READING GLASSES. THE PATIENT REPORTED THAT THE DOCTOR SAID PART OF THE ISSUE WAS THAT THE PATIENT HAD LIGHT EYES (BLUE). THE PATIENT STATED THESE LENSES SHOULD NEVER BE PUT IN ANY LIGHT EYES.
Patient problems: Visual Disturbances
MAUDE report 24129247 ↗MalfunctionJul 11, 2025Break; Break
A NURSE REPORTED WITH A DESCRIPTION OF HAPTIC WAS TORN WHEN LOADING AND SHOOTING BEFORE CATARACT SURGERY WITH IOL IMPLANT. THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 22478581 ↗MalfunctionJun 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A TEAR WAS OBSERVED AT THE EDGE OF THE LENS, SO IT WAS REPLACED WITH A NEW ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22298103 ↗MalfunctionJun 4, 2025Break; Product Quality Problem; Break; Product Quality Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22139771 ↗InjuryMay 9, 2025Optical Decentration; Material Twisted/Bent; Optical Decentration; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAPTICS WAS BENT BUT IOL WAS STABLE IN THE BAG. AFTER 1 DAY POST OPERATIVE IOL WAS DECENTERED AND ONE OF HAPTIC WAS DEFORMED THE DOCTOR DID EXCHANGE WITH A NEW ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21995727 ↗InjuryMay 5, 2025Adverse 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, LENS WAS EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21959609 ↗MalfunctionMar 4, 2025Break; Break
A NURSE REPORTED THAT DURING SURGERY NOTICED THE TEARS WHERE IN MULTIPLE LOCATIONS, FROM HAPTIC TO LENS, IT WAS REMOVED IN A SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT ISSUE WAS NOTED DURING THE INSERTION OF THE LENS THROUGH THE INJECTOR AFTER PREPARATION. LENS REMOVED DURING INITIAL PROCEDURE, THEN DESTROYED AND BACK UP LENS INSERTED.
Patient problems: Insufficient Information
MAUDE report 21513337 ↗MalfunctionDec 26, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21019301 ↗InjuryDec 12, 2024Optical Decentration; Optical Decentration
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE DECENTERED IOL. THE CLINICAL REASON WAS REPORTED TO BE DECENTERED IOL. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY ONE MONTH AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20912745 ↗InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE IOL WAS EXCHANGED FOR ANOTHER MODEL UNSPECIFIED DIOPTER COMPANY LENS.
Patient problems: Halo; Visual Disturbances
MAUDE report 19958901 ↗InjuryAug 6, 2024Adverse 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 REFRACTIVE ERROR. CLINICAL REASON BEING MYOPIC RESULTS. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 19919211 ↗InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, HAD EXPERIENCED A SIGNIFICANT LOSS OF LONG-DISTANCE AND MIDDLE-DISTANCE VISION, ALTHOUGH THEY RETAINED THE ABILITY TO READ UP CLOSE. THE VISION REMAINED UNCLEAR, WITH PERSISTENT HAZINESS AND CLOUDINESS. THE CONSUMER ALSO REPORTED ABOUT CONSISTENT FLOATERS AND SURPRISING FLASHES IN THE CORNERS OF BOTH EYES. THE CONSUMER HAD UNDERWENT SURGERY FOR A RETINAL TEAR AND VITREOUS HEMORRHAGE A FIVE WEEKS AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE AND ALSO UNDERWENT YTTRIUM ALUMINUM GARNET (YAG) LASER SURGERY WAS PERFORMED. EVEN AFTER 14 MONTHS AFTER PROCEDURE, THE ISSUES WERE PERSISTENT AT THE TIME OF REPORTING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION RECEIVED STATING THAT EYE DROPS WERE USED AS MEDICAL INTERVENTION.
Patient problems: Blurred Vision; Retinal Tear; Visual Disturbances; Vitreous Floaters; Vitreous Hemorrhage
MAUDE report 19654989 ↗InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED STATING THAT, IT HAD BEEN OVER TWO YEARS SINCE MY MULTIPLE SURGERIES. NONE OF THE ITEMS HAD IMPROVED. BOTH EYES CONTINUE TO HAVE FLOATERS ON A CONSISTENT BASIS. BOTH EYES REMAIN CLOUDY AT ALL THE TIMES, REGARDLESS OF TIME OF DAY OR CONDITIONS.
Patient problems: Blurred Vision; Retinal Tear; Visual Disturbances; Vitreous Floaters
MAUDE report 19631982 ↗MalfunctionMar 4, 2024Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, SCRATCH ON THE LENS WAS NOTICED. THE LENS WAS REMOVED IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED. THE SURGEON WAS NOT SURE IF THE EVENT WAS DEVICE RELATED OR NOT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18825620 ↗InjuryFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT ABLE TO READ. CLINICAL REASON AS MENTIONED AS ASTIGMATISM AND SUBLUXED IOL EXCHANGE . THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL TWO MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 18788007 ↗InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE DIFFERENT LENS MODE OF DIOPTER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.
Patient problems: Halo; Visual Disturbances
MAUDE report 18483646 ↗InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED LIGHT SCATTERING AND BLURRED VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 18416763 ↗MalfunctionNov 21, 2023Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT THEY NOTICED AN IOL DID NOT ADVANCE IN INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18180426 ↗InjuryMay 16, 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 WAS UNHAPPY. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. NO ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16937317 ↗InjuryMar 14, 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: Blurred Vision; No Clinical Signs, Symptoms or Conditions
MAUDE report 16538589 ↗InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED BLURRY DISTANCE VISION AND SHADOWS AT NEAR WHEN READING. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 16493915 ↗InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A MATERIALS MANAGER REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS UNRESOLVING DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS RECEIVED STATING SHATTERED GLASS AND SPOKES OF LIGHT, POSITIVE DYSPHOTOPSIA AND DRIVING DAY AND NIGHT AND DIFFRACTIVE OPTICS. PATIENT'S SYMPTOMS WERE RESOLVED. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 16332936 ↗InjuryOct 11, 2022Adverse 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 INCREASED INTRAOCULAR PRESSURE AT 33 MMHG , BETA-BLOCKER EYEDROP MEDICINE WAS STARTED TWICE A DAY. ONE WEEK FOLLOW-UP THE INTRAOCULAR PRESSURE WAS CONFIRMED TO BE WITHIN THE NORMAL RANGE, AND THE EYEDROPS WERE DISCONTINUED.
Patient problems: Intraocular Pressure Increased
MAUDE report 15578848 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page