Clareon CNWTT0 (UDI 00380652408080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652408080), received between Jan 16, 2024 and Jan 2, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Delivery” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Inaccurate Delivery

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS INSERTED INTO THE INJECTOR AS NORMAL, BUT IT POPPED OUT. THE SPECIALIST DID NOT CONTINUE THE PROCEDURE AND POSTPONED THE IMPLANTATION UNTIL A SECOND SURGICAL SESSION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23943836 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE PATIENT VISION HAS NOT IMPROVED. HE CAN READ OK, BUT COMPUTER AND DRIVING WERE NOT CLEAR. THE EYEGLASSES HELP BUT SURGEON ENCOURAGED HIM NOT TO WEAR THEM SO HIS VISION COULD IMPROVE. HE SAW HIS SURGEON LAST WEEK AND REALLY DIDN'T GET ANY ADDITIONAL INFORMATION EXCEPT THAT THE SURGEON SAID HE NO LONGER HAS THE LASER THAT WOULD HELP TO IMPROVE HIS VISION. HE WILL ALSO HAVE A 2ND OPINION AT A FACILITY WHO IS ABLE TO USE A VISION CORRECTING LASER.

  Patient problems: Blurred Vision

  MAUDE report 22771087 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL AFTER SURGERY REPORTED THAT PATIENT EXPERIENCED SEVERE HALOS IN THE LEFT EYE WHICH ARE CAUSING HER TO BE HOMEBOUND BECAUSE SHE CANNOT DRIVE. THE IOL (INTRAOCULAR LENS) WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAVE BEEN RECEIVED AND IT STATES THAT THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAVE BEEN RECEIVED AND IT STATES THAT THE PATIENT WAS EXPERIENCED EXTREME HALO'S THAT SHE COULD NOT TOLERATE AND LENS WAS EXCHANGED IN THE LEFT EYE. PATIENT RETURNED FOR A POST OPERATION VISIT AND HAD A CORNEAL FILAMENT REMOVED. VISION HAS INCREASED BY APPROX. 50 PERCENT SINCE EXCHANGE. PATIENT CAME IN ON NEXT MONTH OBSERVED THAT VISION WAS BETTER. PATIENT WAS REFERRED TO A RETINAL SPECIALIST TO VERIFY POSITION OF THE IOL. SHE WAS SEEN BY RETINA. PATIENT WAS FOUND TO HAVE A VITREOUS PROLAPSE, IOL IN GOOD POSITION.

  Patient problems: Prolapse; Visual Disturbances

  MAUDE report 21881363 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISION AND LIGHT BLUR VISION WAS NOT 50 PERCENT OF CORRECTED VISION. THE IOL WAS EXCHANGED FOR ANOTHER UNSPECIFIED MODEL LENS 2 WEEKS 3 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20633475 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRED VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS RESIDUAL REFRACTIVE ERROR.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18744862 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE CAUSE OF THE ISSUE IS DUE TO MASTER CALCULATIONS INACCURATE.

  Patient problems: Blurred Vision

  MAUDE report 18516623 ↗