Clareon CNWTT0 (UDI 00380652408035)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652408035), received between Jun 9, 2023 and Mar 4, 2026 — classified as 5 injuries, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Adverse 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 PATIENT EXPERIENCED LOSS OF CONTRAST. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE LOSS OF CONTRAST, POOR ADAPTATION TO IOL. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY ONE YEAR AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision

  MAUDE report 24510779 ↗
• MalfunctionSep 8, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED HAPTIC BENT/CRIMPED/DISTORTED/TWISTED DURING LOADING WITH NO PATIENT CONTACT AND THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993747 ↗
• InjuryJul 25, 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED GLARE PREVENTS PATIENT'S ABILITY TO DRIVE AT NIGHT. CLINICAL REASON FOR EXPLANT IS GLARE IS, PATIENT FEELS UNSAFE DRIVING AT NIGHT. ALSO STATED VISION WAS GOOD DURING DAY TIME.THE IOL WAS REPLACED WITH UNSPECIFIED MONOFOCAL LENS APPROXIMATELY WITHIN A FOUR MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 22609800 ↗
• MalfunctionJul 25, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANT PROCEDURE THE ANTERIOR HAPTIC WAS TORN AND ENDED UP IN THE ANTERIOR CHAMBER OF THE EYE. THE IOL WAS REMOVE AND SURGERY WAS COMPLETED BY USING SAME COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT'S CURRENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609344 ↗
• InjuryJul 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND FLICKERING. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS LENS WAS DISLOCATED. THE LENS WAS EXPLANTED AND EXCHANGED WITH UNSPECIFIED LENS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LENS WAS REPLACED WITH OTHER COMPANY LENS. THE SYMPTOMS WERE RESOLVED . THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22403176 ↗
• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED IRRITATION IN THE EYE ON THE FIRST DAY POST-OPERATION AND STARTED USING DROPS. AFTER FOUR WEEKS, THE PATIENT¿S LEFT EYE WAS BLURRY ALL THE TIME AND HURT. THE LENS WAS EXCHANGED FOR AN UNKNOWN IOL ONE MONTH AFTER THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Blurred Vision; Eye Irritation; Eye Pain; Visual Impairment

  MAUDE report 20804059 ↗
• InjuryJun 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL ACUITY DISTANCE 0.3 (CORRECTED 0.4) AND POSSIBILITY OF CENTER OFFSET AND DEVIATION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 17097741 ↗