Clareon™ CNWTT3 (UDI 00380652468558)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652468558), received between Jul 11, 2022 and Mar 11, 2026 — classified as 6 injuries, 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Failure to Unfold or Unwrap

  A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, THE HAPTIC REMAINS GLUED TO THE OPTIC AND NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE HAPTIC REMAIN STUCK TO THE OPTIC INSIDE THE PATIENT EYE. THE LENS WAS EXPLANTED AND RE-IMPLANTED IN THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, ANTERIOR HAPTIC WAS STUCK TO THE OPTIC. A MANUAL DEPLOYMENT WAS ATTEMPTED BEFORE EXPLANTATION AND NO ABNORMAL RESISTANCE WAS ENCOUNTERED DURING INSERTION. THE SURGERY WAS COMPLETED DURING THE SAME PROCEDURE WITH BACK UP LENS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568468 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT EXPERIENCED HALOS AND COULD NOT DRIVE AT NIGHT. THE HALOS WAS VERY BAD AROUND THE LIGHTS THAT HE COULD NOT DRIVE AT NIGHT. THERE ARE TWO FILES ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.

  Patient problems: Headache; Visual Disturbances

  MAUDE report 24158659 ↗
• MalfunctionNov 27, 2025Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE OPTIC WAS DAMAGED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS HAD BEEN REMOVED DURING INITIAL PROCEDURE (IN AND OUT) AND REPLACED WITH ANOTHER BACKUP LENS.

  Patient problems: Insufficient Information

  MAUDE report 23666074 ↗
• MalfunctionOct 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON NOTICED LENS OPTIC CRACKED WHEN THE LENS WAS PUSHED TO THE EDGE OF CARTRIDGE. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413984 ↗
• MalfunctionOct 15, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS SCRATCHED BY THE INJECTOR. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE SCRATCH WAS IDENTIFIED BY THE SURGEON UNDER THE MICROSCOPE DURING LENS INSERTION. THE LENS WAS NOT IMPLANTED BUT REMOVED BEFORE FULL INSERTION. NO HARM WAS CAUSED TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299515 ↗
• MalfunctionMay 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE,RESIDUAL REFRACTIVE ERROR, TORIC WAS LOCATED AT 10 DEGREES (ORIGINALLY CALCULATED AXIS WAS 172). PATIENT WAS HAVING ASTIGMATISM AND IT RESOLVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 22088392 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH THE REFRACTION OUTCOME. THE LENS WAS EXPLANTED FOLLOWING THE INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS.

  Patient problems: Visual Impairment

  MAUDE report 20520661 ↗
• InjuryJun 12, 2024Adverse 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 BLURRY VISIO AND UNABLE TO READ STREET SIGNS. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MECHANICAL COMPLICATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19521048 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED PERSISTENT GLARE AND HALOS. YAG LASER SURGERY WAS PERFORMED BUT HAS NOT HELPED. HEALTH CARE PROFESSIONAL REPORTED THE PATIENT BELIEVED THAT THE QUALITY OF LIFE HAS BEEN SEVERELY IMPACTED WITH NO HARM. THE SURGEON¿S PROGNOSIS INCLUDED PATIENT WAS STABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 19213475 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, PATIENT HAD BLURRED VISUAL ACUITY. CLINICAL REASON WAS MENTIONED AS MYOPIC OUTCOME. THE IOL WAS EXCHANGED APPROXIMATELY 7 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18289877 ↗
• InjuryAug 29, 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 WAS UNABLE TO ADAPT TO THE IMPLANT AND COMPLAINED OF GLARE. THE PATIENT'S CORRECTED VISION WAS 0.9, BUT THEIR VISION DID NOT RECOVER AND REMAINED BELOW 0.5. THE IOL WAS EXCHANGED FOR COMPANY MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 17641909 ↗
• MalfunctionJul 11, 2022Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A SCRATCH. THERE WAS A PATIENT CONTACT, AND THE SURGERY WAS COMPLETED THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT ISSUE WITH LENS WAS NOTED AFTER THE LENS WAS INSERTED. THE PATIENT RECEIVED THE REPLACEMENT LENS. THE SURGEON WAS NOT SURE HOW SCRATCH HAS OCCURRED. THERE WAS A PATIENT CONTACT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 14977899 ↗