Clareon CNWET3 (UDI 00380652466455)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652466455), received between Aug 11, 2023 and May 7, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED HAPTIC WAS TORN AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112090 ↗
• MalfunctionSep 4, 2025Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CENTRAL DEFECT / SCRATCH ON OPTICS - POSSIBLY WHEN INSERTING THROUGH THE TWEEZERS. DURING THE OPERATION AFTER IMPLANTATION OF THE IOL, A CENTRAL DEFECT / SCRATCH ON THE OPTICS IS NOTICED. THE DAMAGE LIKELY OCCURRED DUE TO CONTACT WITH TWEEZERS DURING THE IOL LOADING PROCESS INTO THE CARTRIDGE. LENS WAS EXPLANTED IN INITIAL PROCEDURE AND REPLACED WITH THE BACKUP LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22963585 ↗
• MalfunctionAug 21, 2025Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON IMPLANTED COMPANY LENS INTO A PATIENT EYE. AS SOON AS IT WAS UNFOLDED, AT THE SLIT LAMP SURGEON WOULD BEST DESCRIBE IT AS A USUAL LIGHT REFLEX OFF THE LENS AS A GLAZING ON THE LENS AND ALSO SOME GLISTENING. THE PATIENT VISION WAS 20/25 WITH A MINOR CORRECTION BUT IT WAS NOTING A WHITE REFLECTION WHICH SURGEON WAS NOT SURE THAT IT WAS RELATED OR NOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22858590 ↗
• MalfunctionJan 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRA OCULAR LENS (IOL) IMPLANTATION PROCEDURE, HAPTIC WAS TORN OR BROKEN DURING IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21191159 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PERFECT VISION ONLY AT CLOSE RANGE, CANNOT ABLE TO IDENTIFY PEOPLE OR OBJECTS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 21046091 ↗
• InjuryJun 13, 2024Material Opacification; Defective Device; Insufficient Device Problem Information; Material Opacification; Defective Device; Insufficient Device Problem Information

  A PHYSICIAN REPORTED WITH A DESCRIPTION OF THE SURGEON PERFORMED R+R ON A PATIENT, REMOVING THE ORIGINAL IMPLANT IN ONE PIECE USING THE TACO TECHNIQUE AND PLACING IT INTO AN ORANGE-TOP SPECIMEN CONTAINER WITH BSS SOLUTION. THE SURGEON IMPLANTED THE NEXT LENS BUT FOUND A DEFECT NEAR THE OPTIC/HAPTIC JUNCTION WITH A SLIGHT 'FILM' AND REMOVED IT USING THE TACO TECHNIQUE. THIS LENS WAS PLACED INTO A WHITE-TOP SPECIMEN CONTAINER WITH BSS. THE BACKUP LENS WAS THEN IMPLANTED, WHICH ALSO HAD A DEFECT AT THE OPTIC/HAPTIC JUNCTION WITH A 'FILM.' A PHOTO WAS TAKEN SHOWING A SMALL DEFECT. THE SURGEON INFORMED THE PATIENT BUT LEFT THE LENS IN PLACE DUE TO A LACK OF ADDITIONAL BACKUPS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT IS POST-LASIK BOTH EYES (OU). CATARACT EXTRACTION IOL RIGHT EYE WAS DONE ON (B)(6) 2024. WHILE THERE WAS A MYOPIC SURPRISE OF APPROXIMATELY 1D SE, THE PATIENT WAS COMPLAINING THAT HE COULD NOT SEE CLEARLY AT ANY DISTANCE AND NO MATTER WHAT PRESCRIPTION WAS SET IN THE PHOROPTER. THERE WAS A SMALL DEFECT PERIPHERALLY IN THE LENS, WITH A BLUE-ISH FILM AT THE PERIPHERY OF THE LENS COMING INWARDS (NOT INVOLVING CENTRE). THE PATIENT SAW 2 OTHER SURGEONS FOR TH

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19531383 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTURBANCE. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 18299628 ↗
• MalfunctionAug 11, 2023Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN NOTICED SCRATCH ON THE LENS. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17510053 ↗