Clareon CNW0T6 (UDI 00380652411127)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652411127), received between Apr 4, 2023 and Feb 3, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Device Dislodged or Dislocated

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRY AND DISTORTED VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 16 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS TORIC AXIS ROTATION CAUSING -20 DIOPTERS OF CYLINDER. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, IN THE SURGEON OPINION THE CAUSE OF THE EVENT WAS DUE TO TORIC AXIS OF IOL WAS SUPPOSED TO BE AT 171 BUT WAS SETTING AT AXIS 007 CAUSED PATIENT REFRACTIVE OUTCOME.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24246581 ↗
• MalfunctionNov 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A CONSUMER (WHO IS ALSO A PHYSICIAN) REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT HAD EXPERIENCED EYE TORIC POWER WAS STILL VERY HIGH / NOT CORRECTED AFTER THE COMPANY TORIC INTRAOCULAR LENS (IOL) IMPLANT. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING SYMPTOMS STARTED APPEARING AFTER 1 WEEK AND CONTINUED AFTER 3 WEEKS, AS VISION CHECK FOUND NO IMPROVEMENT IN TERMS OF CYLINDRICAL POWER AND AXIS. THE PATIENT HAD CYLINDRICAL POWER AND AXIS IN SPITE OF USING COMPANY TORIC INTRAOCULAR LENS (IOL) AND READABILITY OF LETTERS WAS NOT GOOD DUE TO BLURRED LETTERS. VISION QUALITY WAS ALSO NOT MUCH IMPROVED AS SHARPNESS, CONTRAST OF PICTURES WERE STILL NOT GOOD. EYE CARE PROVIDER NOT COMMENTED AS SUCH WHY TORIC POWER IOL FAILED TO CORRECT CYLINDRICAL POWER AND AXIS. AS PER EYE CARE PROVIDER PROBLEMS RELATED TO PICTURE QUALITY MAY BE DUE TO OTHER EYE ISSUES. ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM PHYSICIAN STATING THAT PATIENT CAME FOR FOLLOW UP 3-4 TIMES. THE PHYSICIAN CONFIRMED THAT PATIENT WAS WELL ADVISED ABOUT THE POWER CORRECTION AFTER SURGERY. THE PATIENT DID NOT COMPLAINT OF RESIDUAL SPECTACLE IN THE LEFT EYE. BEFORE SURGERY PATIENT REQUESTED

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20799334 ↗
• MalfunctionApr 4, 2023Break; Device Contamination with Chemical or Other Material; Break; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT ONCE THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, A FOREIGN MATERIAL WAS OBSERVED ON THE TRAILING HAPTIC. THE IOL WAS REMOVED DURING SURGERY BECAUSE THE FOREIGN MATERIAL COULD NOT BE REMOVED BY IRRIGATION & ASPIRATION. WHEN IOL WAS REMOVED, THE TRAILING HAPTIC WAS CHECKED, AND IT (TRAILING HAPTIC) WAS CLEARLY ATTACHED. THE DOCTOR SAID THAT THE LENS SEEMED TO HAVE MELTED. THE SURGERY WAS COMPLETED AFTER REPLACING THE IOL WITH ANOTHER ONE IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16672062 ↗