Clareon CNWET0 (UDI 00380652405201)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652405201), received between Dec 23, 2022 and May 13, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WAS WORSE AFTER SURGERY THAN BEFORE. ADDITIONALLY PATIENT STATED THAT VISION WAS NOT CLEAR, EVEN WITH GLASSES AND THINGS HAVE A SHADOW OFF TO THE RIGHT, CANNOT DRIVE AT NIGHT DUE TO HALOS AND INABILITY TO SEE ROAD SIGNS. HAD SEEN A RETINAL SPECIALIST AND WAS TOLD EYES WERE FINE. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22014282 ↗
• MalfunctionMar 12, 2024Defective Device; Defective Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WITH A DESCRIPTION OF DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18885595 ↗
• 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 2 OF 2.

  Patient problems: Blurred Vision

  MAUDE report 18408740 ↗
• InjuryDec 26, 2023Adverse 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, THE PATIENT EXPERIENCED LIMITED INTERMEDIATE RANGE OF VISION. CLINICAL REASON BEING DID NOT ACHIEVE ADEQUATE INTERMEDIATE RANGE OF VISION, TRANSITION TO TRIFOCAL. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 18392107 ↗
• InjuryDec 23, 2022Adverse 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 POOR VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS POOR VISION. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 16041703 ↗