Clareon CNWET0 (UDI 00380652405294)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652405294), received between Jan 3, 2024 and Jun 23, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Break

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AS DURING THE IOL¿S MOVEMENT INSIDE THE CARTRIDGE BEFORE IMPLANTATION, THE INJECTOR PLUNGER DEVIATED, CAUSING THE IOL HAPTIC TO TEAR. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25597210 ↗
• InjuryMay 7, 2026Insufficient Device Problem Information

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25113236 ↗
• MalfunctionDec 29, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IOL FOUND TO HAVE HAPTIC ISSUE HENCE COULD NOT BE IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23906180 ↗
• MalfunctionMar 25, 2025Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH WAS OBSERVED ON THE IOL OPTIC AFTER IMPLANTATION. LENS WAS EXPLANTED IN INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH BACK UP LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689812 ↗
• MalfunctionJan 13, 2025Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON COULD NOT MAKE THE LENS ENGAGE WITH THE CARTRIDGE TO LOAD INTO INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21136087 ↗
• MalfunctionDec 5, 2024Unintended Ejection; Unintended Ejection

  A NURSE REPORTED THAT BEFORE SURGERY THEY HAD NOTICED THAT HAPTIC CAUGHT IN INCISION, THEREFORE NOT IMPLANTED. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT LEADING HAPTIC WAS INVOLVED, SURGERY WAS COMPLETED WITH REPLACEMENT LENS.

  Patient problems: Insufficient Information

  MAUDE report 20851187 ↗
• MalfunctionSep 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, A CRACK IN THE CENTER OF THE OPTIC WAS NOTICED. THE DOCTOR HAD TO DO AN IOL EXCHANGE DURING SAME PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20146751 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRY VISION, DIFFICULTY SEEING DRIVING. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 06 MONTHS 01 DAY FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS POSITIVE DYSPHOTOPSIA & GENERAL DYSPHOTOPSIA.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19497464 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT HIMSELF REQUESTED THE DOCTOR TO IMPLANT THE LENS AS PER HIS RESEARCH, DOCTOR HAD EXPLAINED HIM EVERYTHING ABOUT THE LENS AND ITS FUNCTIONAL NEAR VISION, IT WAS ALSO TOLD THAT HE MAY REQUIRE THE GLASSES AFTER THE SURGERY. PATIENT HAD CATARACT ONLY IN ONE EYE AND NOW AFTER THE SURGERY HE WAS COMPARING THE VISION WITH THE NON CATARACT EYE AND FINDING IT DIFFERENT. DOCTOR TOLD THAT THE PATIENT HAD A POSTERIOR SUBCAPSULAR CATARACT AND CLEARLY EXPLAINED HIM BEFORE THE SURGERY. AFTER THE SURGERY, PATIENT WAS EXPLAINED ABOUT THE YAG LASER FOR CLEAR VISION AND ASKED HIM TO VISIT BUT HE DID NOT TURN UP. UPDATE FROM THE PATIENT STATES THAT HE WAS USING THE PRESCRIBED SPECTACLES, BUT NOT VERY COMFORTABLE WITH THE VISION.

  Patient problems: Blurred Vision

  MAUDE report 18855479 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER HAVING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY IN THE RIGHT EYE, THE VISION WAS STILL FUZZY CENTRALLY. THE NEAR VISION AND PERIPHERAL VISION WAS GOOD, BUT CONSUMER HAD TROUBLE WITH CENTRAL VISION AT DISTANCE. CONSUMER ALSO HAD TROUBLE WITH BRIGHT LIGHTS. ADDITIONAL INFORMATION WAS RECEIVED. THE VISION WAS STILL NOT GOOD. CONSUMER STATED THAT THE MORNING VISION WAS NOT THE BEST AND CONSUMER HAD SOMEWHAT BLURRY VISION STRAIGHT ON, BUT IF THE CONSUMER TILTED THE HEAD, IT WAS MORE CLEAR THROUGH SIDE VISION. CONSUMER WENT TO OPTOMETRIST WHO INSISTED THAT THE LENS WAS IN THE CORRECT SPOT. THE OPTOMETRIST SUGGESTED TO USE EYE DROPS FOR ONE MONTH. BUT THERE WAS NO IMPROVEMENT. THE OPTOMETRIST ALSO SUGGESTED SOME GLASSES, BUT COULD NOT FIND A LENS THAT WOULD CORRECT IT. THE CONSUMER ALSO HAD AWFUL GLARE IN BRIGHTLY LIT AREAS, SUCH AS STORES.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18433397 ↗