Clareon™ CNWTT4 (UDI 00380652469036)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable Diffractive Aspheric Toric Posterior Chamber Intraocular Lens · Class 3 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652469036), received between Dec 12, 2024 and Aug 11, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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 Problem4
- Break1
- Device Dislodged or Dislocated1
- Optical Decentration1
Patient problems
- Blurred Vision4
- Visual Disturbances2
- Visual Impairment2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
A health care professional reported that following an intraocular lens (IOL) implant procedure, the patient experienced with glare/halo effects. The lens was exchanged for another lens following the initial procedure.Additional information has been requested but is not available at the time of this report.
Patient problems: Visual Disturbances
MAUDE report 50207440 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION IN HER LEFT EYE, SHE WAS NOT ABLE TO SEE PROPERLY. SHE WAS UNHAPPY WITH THE NEAR VISION RESULTS; ALTHOUGH SHE HAD BEEN INFORMED THAT SHE WOULD NOT NEED READING GLASSES WITH THIS LENS, SHE WAS STILL UNABLE TO READ PRINTED MATERIAL WITHOUT THEM. SHE MENTIONED THAT SHE HAD TRIED USING A CONTACT LENS ON THE EYE TO IMPROVE HER VISION BUT DID NOT WANT TO CONTINUE USING CONTACTS. SHE STATED THAT HER SURGEON IS CONSIDERING REMOVING THE IOL. SHE ALSO NOTED THAT SHE HAS AN UPCOMING APPOINTMENT WITH THE SURGEON.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 24496151 ↗InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT¿S VISION BECAME UNCLEAR. ACCORDING TO THE SURGEON, IT WAS BELIEVED THAT THE INSERTION OF THE IOL HAD CAUSED THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED LENS DURING A SECONDARY IMPLANT PROCEDURE.
Patient problems: Blurred Vision
MAUDE report 24414597 ↗InjuryJul 10, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED GREY LINE OFF TO LEFT SIDE OF VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS TEMPORAL DISLOCATION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PATIENT WAS DIAGNOSED WITH SUBLUXATION OF LENS WITH 2MM TEMPORAL DISLOCATION LATERALLY. IN THE SURGEON'S OPINION, ONE OF THE HAPTICS WAS NOT ATTACHED TO THE LENS. THIS COULD HAVE CONTRIBUTED TO THE MISALIGNMENT OF THE LENS. THE PATIENT'S ISSUE WAS RESOLVED AND THE PATIENT WAS STABLE AND UNRESTRICTED. THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 22468799 ↗InjuryJan 27, 2025Optical Decentration; Optical Decentration
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY DISTANCE VISION LEFT EYE, READING AND INTERMEDIATE, INTRA OCULAR LENS WAS DECENTERED. CLINICAL REASON FOR EXPLANT POOR INTRA OCULAR LENS SUPPORT. THE IOL WAS EXCHANGED WITH NON COMPANY INTRAOCULAR LENS 1 MONTHS 5DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 21240832 ↗InjuryDec 12, 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,LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO REFRACTION ISSUE. THE CLINICAL REASON WAS REPORTED TO BE "REVERSE AXIS OF CYLINDER". THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY ONE MONTH AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 20914487 ↗
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 OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.