Clareon CNWTT0 (UDI 00380652408202)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Clareon CNWTT0 is a foldable intraocular lens used to replace the eye's natural lens during cataract surgery. The 29 reports mostly describe lens damage noticed during or after surgery — scratches, cracks, splits, or bent haptics that left the lens unstable, and one case where the lens would not come out of the injector — along with vision problems such as blurred vision and large halos around lights. Seven reports involve injuries and no deaths are described. 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
- 29
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00380652408202), received between Aug 29, 2023 and Aug 6, 2026 — classified as 7 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (9 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
- Scratched Material9
- Adverse Event Without Identified Device or Use Problem6
- Break5
- Material Split, Cut or Torn4
- Material Twisted/Bent3
- Failure to Eject2
- Crack1
- Defective Device1
Patient problems
- Insufficient Information13
- No Clinical Signs, Symptoms or Conditions11
- Visual Impairment4
- Blurred Vision3
- Halo1
- Retinal Degeneration1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50158483 ↗MalfunctionApr 15, 2026Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS DAMAGED AND HAD A SCRATCH ON IT. THE INITIAL PROCEDURE WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24891990 ↗InjuryMar 20, 2026Material Twisted/Bent
ADMINISTRATOR/SUPERVISOR REPORTED THAT DURING SURGERY HAPTICS WAS BENT AND IT WAS IN AN OVERLAPPING POSITION, NOTICED AFTER IMPLANTATION. SO, THE DOCTOR REPOSITIONED IT AND LEFT THE LENS IMPLANTED. THE NEXT DAY, DURING THE FOLLOW-UP EXAMINATION, THEY IDENTIFIED THAT THE LENS WAS NOT STABLE SO THEY HAVE EXPLANTED THE LENS AND ANOTHER LENS WAS IMPLANTED WITHOUT ANY FURTHER HARM TO THE PATIENT AND THE CURRENT CONDITION REMAINS UNCHANGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24650152 ↗MalfunctionMar 17, 2026Material Split, Cut or Torn
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF CRACKED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24617109 ↗MalfunctionFeb 13, 2026Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH ON THE LENS WAS NOTICED AND PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24331058 ↗MalfunctionFeb 6, 2026Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN SURGEON WAS INSERTING THE LENS IN THE EYE, SURGEON VERBALIZED WHEN ROTATING FORWARD THE INJECTOR FOR THE IOL GO IN THE EYE, NOTICED THAT THE TIP OF THE INJECTOR WAS ABOVE THE LENS. THE INITIAL LENS HAD A SCRATCH LOCATED AT THE CENTER OF THE LENS AND SCRUB NURSE RELOADED A NEW LENS. THE SURGEON DECIDED TO CUT AND EXPLANT THE IOL AND INSERTED A NEW ONE AND USED COMPANY ANOTHER INJECTOR.
Patient problems: Insufficient Information
MAUDE report 24279561 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SHE EXPERIENCED WITH HALOS SO BIG IN THE NIGHTTIME AND LOOKING AT ANY BRIGHT LIGHTS LIKE CAR LIGHTS, SIGNAL LIGHTS, BIKE LIGHTS, TORCH LIGHTS, DECORATION LIGHTS, STREETLIGHTS AND CANNOT EVEN SEE THE SOURCE OF THE LIGHTS. WHICH MADE HER DIFFICULT TO GET OUT OF THE HOUSE IN THE NIGHTTIME AND MAKING DRIVING IMPOSSIBLE AS THE HALLOW LIGHTS FROM THE CARS OPPOSITE SIDE REFLECTION MAKING IMPOSSIBLE TO SEE SIDE OF THE LANE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 05 MONTHS 06 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Halo
MAUDE report 24053257 ↗InjuryDec 11, 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 EXPERIENCED BLURRED VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ADVANCED TECHNOLOGY INTRAOCULAR LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS REFRACTIVE ERROR. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23776950 ↗MalfunctionDec 5, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY THE LENS WAS LOADED INTO THE INJECTOR AND A 2.2 MM INCISION WAS CONFIRMED. UPON DEPLOYMENT, THE PROXIMAL HAPTIC WAS FOUND TO BE BROKEN. THE LENS REMAINED IN THE CAPSULAR BAG BUT IT WAS OBSERVED THAT THE LENS WAS DECENTERED. THE PATIENT WAS RESCHEDULED FOR LENS REMOVAL.
Patient problems: Insufficient Information
MAUDE report 23729988 ↗MalfunctionNov 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WAS CRACKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23671893 ↗MalfunctionNov 10, 2025Material Twisted/Bent; Material Twisted/Bent
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE HAPTIC WAS DEFECTIVE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23512206 ↗MalfunctionOct 28, 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 23402370 ↗MalfunctionAug 21, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE THE HAPTICS WAS TORN INTO THE CARTRIDGE DURING THE IOL LOADING. THE LOWER HAPTICS CALMLY BENT, AND THE UPPER ONE, RIGHT AT THE EDGE OF THE HAPTICS AND OPTICS, SMOOTHLY SEPARATED. THE SURGERY WAS COMPLETED WITH THE COMPANY LENS. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22857509 ↗InjuryJul 28, 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 REASON AS MYOPIC SURPRISE AND CLINICAL REASON FOR EXPLANT BEING DID NOT MEET REFRACTIVE GOAL, CANNOT READ. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 22630993 ↗InjuryJul 28, 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, THE PATIENT EXPERIENCED POOR VISUAL OUTCOME AND NOT SATISFACTORY AS PER SURGEON. IT WAS ALSO STATED THAT PATIENT WAS EXPERIENCING EPIRETINAL MEMBRANE AND RETINAL ISSUES WHICH WERE NOT DETECTED PRIOR TO IMPLANT. THE LENS WAS EXPLANTED BY A NON-COMPANY LENS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT FURTHER TREATMENT AND POTENTIALLY SECONDARY SULCUS IOL ON TOP OF EXPLANTED PANOPTIX/ NEW EYHANCE IOL.
Patient problems: Retinal Degeneration; Visual Impairment
MAUDE report 22629521 ↗MalfunctionJul 25, 2025Scratched Material; Scratched Material
A SURGEON REPORTED THAT DURING INTRAOCULAR LENS IMPLANT PROCEDURE NOTICED A SMALL MARK OR CRACK ON PERIPHERY OF LENS. SURGEON HEARD THERE MIGHT BE DEFECTS ON CARTRIDGE. THERE WAS PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 22608890 ↗MalfunctionJul 24, 2025Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANT PROCEDURE NOTICED A SMALL MARK OR CRACK ON CENTRAL PART OF LENS. SURGEON HEARD THERE MIGHT BE DEFECTS ON CARTRIDGE. THE LENS WAS LEFT IMPLANTED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22586370 ↗MalfunctionApr 23, 2025Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE WHEN TRYING TO LOAD THE LENS, SURGEON NOTICED A SCRATCH IN THE OPTICAL AREA AND IT WAS NOT INTENDED TO BE IMPLANTED, TO PREVENT REFRACTIVE RESULT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21893009 ↗MalfunctionMar 18, 2025Device Damaged Prior to Use; Failure to Deliver; Device Damaged by Another Device; Packaging Problem; Device Damaged Prior to Use; Failure to Deliver; Device Damaged by Another Device; Packaging Problem
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE LENS WAS INJECTED INTO A 2.4 MM WIDE INCISION. HALFWAY INTO THE ANTERIOR CHAMBER, IT GOT STUCK AND IT WAS IMPOSSIBLE TO COMPLETE THE IMPLANTATION. THE SURGERY WAS COMPLETED USING THE REPLACEMENT LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21629955 ↗MalfunctionMar 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CUT NEAR THE TRAILING HAPTIC WAS OBSERVED. AS IOL WAS NOT INSPECTED PRE OPERATIVELY UNABLE TO SAY IF IT WAS THERE PRIOR TO LOADING. IOL LEFT IN THE EYE. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NOTCH IN LENS NEAR HAPTIC JUNCTION.
Patient problems: Insufficient Information
MAUDE report 21606663 ↗MalfunctionMar 13, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACK WAS OBSERVED IN THE POSTERIOR HAPTIC WHILE THE LENS WAS BEING IMPLANT. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21596901 ↗MalfunctionJan 2, 2025Defective Device; Failure to Eject; Defective Device; Failure to Eject
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND SATED THAT THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21056501 ↗MalfunctionNov 15, 2024Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SMALL INDENTATION/MARK ON IOL. THEY DISCUSSED POTENTIALLY LOADING TECHNIQUE ISSUES AND INJECTORS NOT BEING USED CORRECTLY AND CAREFULLY BY NURSING STAFF. THERE WAS NO PATIENT CONTACT AND HARM. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT WAS UNAFFECTED AND LENS WAS STILL IN THE EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20695736 ↗MalfunctionOct 2, 2024Crack; Crack
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED A TEAR ON THE PERIPHERAL OF THE INTRAOCULAR LENS AFTER IMPLANTATION.
Patient problems: Insufficient Information
MAUDE report 20350083 ↗InjurySep 13, 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 BLURRY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS PATIENT UNHAPPY WITH QUALITY OF VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 20209991 ↗
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 OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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