Clareon CNWET3 (UDI 00380652466394)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652466394), received between May 17, 2023 and Jul 9, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Device Dislodged or Dislocated; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POOR MIDRANGE AND NEAR VISION. HENCE, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANTATION WAS A DAMAGED LENS HAPTIC, WHICH DID NOT REMAIN CENTERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED, STATING THAT THE SURGEON WHO PERFORMED THE SURGERY NOTED LENS DECENTRATION AND A COMPLAINT OF POOR NEAR VISION ON THE FIRST POST-OPERATIVE DAY. DAMAGE TO THE LENS HAPTIC WAS NOT NOTICED UNTIL INTRAOPERATIVELY DURING THE IOL EXCHANGE, AS THE LENS OPTIC-HAPTIC JUNCTION WAS NOT VISIBLE ON DILATED EXAMINATION FOLLOWING THE FIRST SURGERY DUE TO THE DECENTRATION. IN THE SURGEON'S OPINION, THE LENS IMPLANT LIKELY BECAME DAMAGED DURING INSERTION USING A COMPANY INJECTOR AND CARTRIDGE. THERE WAS NO FURTHER IMPACT ON THE PATIENT, AND THE SURGEON'S PROGNOSIS WAS EXCELLENT.

  Patient problems: Blurred Vision

  MAUDE report 25769456 ↗
• MalfunctionMar 6, 2026Failure to Deliver; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CUSTOMER WAS PREPARING TO INJECT THE LENS AND CHECKING THAT IT WAS ADVANCING UNDER THE MICROSCOPE BUT IT WAS NOT ADVANCING PROPERLY. SHE TRIED TO MANOEUVRE IT BUT THE HAPTIC WAS STICKING OUT AWKWARDLY AND SHE WAS NOT HAPPY TO PROCEED. THE SURGERY WAS COMPLETED ON THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 24531944 ↗
• MalfunctionFeb 18, 2025Product Quality Problem; Failure to Deliver; Product Quality Problem; Failure to Deliver

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FAILED NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 21397365 ↗
• MalfunctionDec 28, 2023Malposition of Device; Malposition of Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REPORTED THAT, CAN'T EVEN SEE COMPUTER SCREEN AND IT IS 26' AWAY. CLOSE VISION I ONLY HAD TO USE 1.25 READERS. CLOSE UP VISION IS THE SAME IF NOT SLIGHTLY WORSE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT¿S CLOSE VISION AND MID VISION ARE NOW WORSE AFTER IMPLANTATION IN EYE. THE PATIENT FEELS LIKE MAY HAVE MESSED EYES UP. THE PHYSICIAN SAID THAT THE LENS IN EYE HAVE SHIFTED BACK SLIGHTLY MAKING IT A PLUS INSTEAD OF A MINUS AND THAT A MINUS IS NEEDED FOR CLOSE VISION. THE PHYSICIAN SUGGESTION WAS TO WEAR READERS 2.25 FOR COMPUTER WORK AND 3.00 FOR READING OR I COULD HAVE LASIK TO FIX IT. THAT DOESN'T SEEM RIGHT. THE VISION FOR CLOSE UP WAS BLURRY EYE IMMEDIATELY AFTER SURGERY. WHEN THE PATIENT ASKED PHYSICIAN AFTER THE FIRST FOLLOW UP, PHYSICIAN SAID IT WAS NORMAL AND TAKES TIME TO FOCUS. THE PATIENT WAS VERY UPSET THAT THE DOCTOR TOLD LENS DIDN'T WORK ON PATIENT EYE. THE PATIENT SAID VISION IS WORSE THAN EVER. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE 1 OF 2.

  Patient problems: Blurred Vision

  MAUDE report 18408744 ↗
• MalfunctionMay 17, 2023Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED CHIPPED EDGES AND SCRATCH IN MIDDLE OF LENS UPON IMPLANTATION, REMOVED AND REPLACED THE LENS IN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16945354 ↗