Clareon CNW0T5 (UDI 00380652410717)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652410717), received between Aug 22, 2024 and Jan 13, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Material Discolored

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS WHITEISH APPEARANCE ON THE LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE FINDING OF THE IOL WAS CONTINUING EVEN AFTER THE SURGERY. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053256 ↗
• MalfunctionSep 2, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS DAMAGED AFTER IMPLANTING THE LENS. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22945471 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED ABOUT AN INTRAOCULAR LENS (IOL) STATING DURING PROCEDURE THERE WAS A PROBLEM WITH THE IOL COATING (THE IOL LOOKED BLUE) AFTER IMPLANTATION. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT LENS STILL REMAINED IN THE PATIENT EYE. THERE WAS NO PATIENT HARM SO FAR. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925442 ↗
• MalfunctionAug 22, 2024Scratched Material; Physical Resistance/Sticking; Scratched Material; Physical Resistance/Sticking

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION OF AN IOL IN THE BAG A SCRATCH WAS FOUND IN THE IOL. THE LENS IMPLANTATION WAS SET UP BY A SUPPORTING DOCTOR, SO THE SURGEON DID NOT SEE THE IOL SETTING PROCESS. DURING IMPLANTATION HE/SHE FELT RESISTANCE A BIT. THEN HE/SHE REALIZED THAT THERE WAS A SCRATCH IN THE IOL. SINCE THE IOL WAS IMPLANTED IN THE BAG ACCURATELY, CONSIDERING THE RISK OF DECREASED VISUAL ACUITY THE SURGERY WAS COMPLETED BY ROTATING THE IOL 180 DEGREES WHILE STILL IN THE PATIENT'S EYE, SO THAT THE SCRATCHED PART WAS FACING UPWARD (TOWARDS THE PATIENT'S HEAD). THE PATIENT FELT LIKE HALO ONLY FOR THIS EYE AND THE SURGEON THOUGHT THAT THIS MIGHT BE DUE TO THE SCRATCH OF IOL AND THE PATIENT WAS PLANNED TO BE MONITORED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20025992 ↗