Clareon CNW0T4 (UDI 00380652410229)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652410229), received between Jul 28, 2023 and Feb 6, 2026 — classified as 2 injuries, 5 malfunctions.

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

• MalfunctionFeb 6, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BROKEN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24275536 ↗
• MalfunctionSep 19, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096018 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 173 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925446 ↗
• MalfunctionApr 29, 2025Particulates; Scratched Material; Particulates; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, RAISED COMPLAINT REGARDING THE SOME MATERIAL ON IOL. IT LOOKED LIKE THREAD AND THAT OBSERVED ONCE OPENED THE WAGON WHEEL. HOWEVER IMPLANTED THE SAME IOL AFTER CLEANING. ALSO OBSERVED SOME DENT ON OPTIC OF IOL AFTER IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21924752 ↗
• InjuryAug 29, 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, DUE TO THE OVER CORRECTION OF THE LENS IN THE POSTERIOR CAPSULE, THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 20096161 ↗
• InjuryFeb 2, 2024Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED -2.25 HIGH ASTIGMATISM AND LENS WAS AT 87° AFTER SURGERY. THE PREOPERATIVE IOL MASTER MEASUREMENT WAS NOT GOOD. THE ASTIGMATISM FROM THE IOL MASTER DOES NOT MATCH THE ASTIGMATISM MEASURED WITH THE PENTACAM. THE WRONG IOL MODEL WAS IMPLANTED IN COMPLETELY WRONG AXIS. A LARGE TILT OF LENS WAS SEEN IN B SCAN. PATIENT DOESN'T SEEM TO BE ABLE TO FOCUS ON THE INFRARED IMAGE AND REFLEXES FROM THE TOPO MEASUREMENT WAS 2X. THE PUPIL COORDINATES SHOW A DECENTRATION OF -1.9MM IN THE X-AXIS. THE IOL TILT CREATES A COMA, WHICH THE PATIENT CAN ASSUME TO BE A CYLINDER DURING REFRACTION. PREOPERATIVE REFRACTION FROM 22-SEP-2023 SHOWS -1DPT@75°. NOTICED A LARGE IOL TILT IN THE B-SCAN FROM 09-JANUARY. THE NATURAL LENS ALSO APPEARS TO BE HEAVILY TILTED IN THE PREOPERATIVE MEASUREMENT. MEASUREMENTS WITH THE IOL-MASTER AND THE PENTACAM ALSO SHOW THE STEEP AXIS MORE TOWARDS 150°. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE SURGEON DOES NOT SUSPECT A PROBLEM WITH THE IOL.

  Patient problems: Visual Impairment

  MAUDE report 18629854 ↗
• MalfunctionJul 28, 2023Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CENTER OF THE IOL OPTIC WAS FOUND SCRATCHED AFTER IMPLANTATION. THE IOL WAS EXCHANGED FOR ANOTHER LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO POTENTIAL HEALTH IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412622 ↗