Clareon CNW0T3 (UDI 00380652409698)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652409698), received between Apr 26, 2023 and May 1, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE SETTING OF DEVICE, THE OPTICS WAS SCRATCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057679 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT UNDERWENT INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY. POST SURGERY PATIENT HAD A COMPLAINT OF CONTINUOUS STARBURST, GLARE AND POSITIVE DYSPHOTOPSIA FROM HEADLIGHT OF VEHICLES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 24769356 ↗
• MalfunctionDec 12, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TORIC MARKERS NOT ALIGNED WITH HAPTIC / TORIC MARKERS ON LENS FOR PLACEMENT WERE NOT IN THE CORRECT AREA. THE SURGEON EXPLANTED AND IMPLANTED COMPANY ANOTHER SAME MODEL TORIC LENS. IN THE SURGEON¿S OPINION PRODUCT CONTRIBUTED TO EVENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796882 ↗
• MalfunctionNov 18, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS SCRATCHED AFTER IMPLANTING THE LENS. THE LENS WAS EXPLANTED LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING SURGEON PROGNOSIS WAS UNKNOWN AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578136 ↗
• InjuryAug 4, 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'S VISION WAS NOT CLEAR. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS UNDESIRED MYOPIA.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22699955 ↗
• InjuryApr 21, 2025Adverse 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 EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH SAME MODEL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS REFRACTIVE ERROR .

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21875037 ↗
• MalfunctionDec 3, 2024Failure to Eject; Failure to Eject

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY THEY HAVE NOTICED THAT THE LENS WAS STUCK IN CARTRIDGE AND WOULD NOT ADVANCE THROUGH CARTRIDGE INTO EYE. PHYSICIAN WAS CONCERNED LENS COULD HAVE BEEN DAMAGED WHILE STUCK. ADDITIONAL INFORMATION HAS RECEIVED IT STATES THAT THERE WAS NO IMPACT TO THE PATIENT AND SCHEDULED PROCEDURE COMPLETED THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834796 ↗
• MalfunctionOct 18, 2024Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER LENS IMPLANTED INTO PATIENT¿S EYE, DOCTOR OBSERVED UNDER MICROSCOPE THAT THERE¿S AN APPROXIMATELY 2MM CRACK AT THE CENTRE OF THE OPTIC. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH THE SAME MODEL BACK UP LENS. CUSTOMER HAS DISPOSED THE DEFECTED LENS DUE TO BIOHAZARD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20479064 ↗
• MalfunctionDec 11, 2023Crack; Crack

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE A CRACK OF APPROXIMATELY 2.0 MM APPEARED NEAR THE CENTER OF THE OPTIC OF THE IOL. THE SURGERY WAS COMPLETED AS IT WAS WITHOUT PRODUCT REPLACEMENT, AND THERE WAS NO EFFECT ON THE POSTOPERATIVE VISUAL ACUITY. THERE WAS NO ABNORMALITY IN THE INJECTOR PLUNGER, AND THE SETTING METHOD HAS NOT CHANGED FROM BEFORE, SO THE PHYSICIAN SUSPECTS A PROBLEM WITH THE CARTRIDGE. THE IOL WAS LEFT IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18302203 ↗
• MalfunctionApr 26, 2023Device Contamination with Chemical or Other Material; Scratched Material; Device Contamination with Chemical or Other Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A SCRATCH OR FOREIGN MATERIAL WAS FOUND IN THE OPTIC AFTER IOL INSERTION. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THE LENS REMAINS IMPLANTED IN PATIENT'S EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16814903 ↗