Clareon CNWTT0 (UDI 00380652407991)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652407991), received between Aug 2, 2022 and Jan 16, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR IMPLANT PROCEDURE, THE HAPTIC WAS TORN. THE LENS WAS EXPLANTED AND NEW IOL WAS IMPLANTED IN SAME SURGERY. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT LENS HAD SCRATCHES. THERE WAS NO PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095324 ↗
• MalfunctionAug 22, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT ONE OF THE LENS HAPTICS WAS BROKEN. THERE WAS NO PATIENT CONTACT. BACK UP LENS WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873568 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER TWO WEEKS OF POST OPERATION THE PATIENT EXPERIENCED INTOLERABLE GLARE AND HALOS BY THE COMPANY LENS SO, THE PATIENT WAS NOT ABLE TO DRIVE DURING THE DAY OR AT NIGHT. EVEN STREETLIGHT'S HAD RINGS AROUND THEM. DUE TO THE SURGERIES, THE PATIENT ALSO HAD INDUCED ASTIGMATISM IN THIS EYE. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS WITH DIFFERENT MODEL IN A SECONDARY PROCEDURE. PATIENT ALSO UNDERWENT YAG (YTTRIUM-ALUMINUM-GARNET) LASER AFTER THE EXCHANGE AND NEED A REFRACTIVE TOUCH UP WITH PRK (PHOTOREFRACTIVE KERATECTOMY). IN THE SURGEON'S OPINION, THE PROGNOSIS OF THE PATIENT WAS GOOD. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 22739423 ↗
• MalfunctionMar 8, 2023Scratched Material; Scratched Material

  A CUSTOMER REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION SOMETHING LIKE A SCRATCH WAS CONFIRMED ON THE LENS OPTICAL PART AFTER IMPLANTING. THE DOCTOR DOES NOT THINK IT WILL AFFECT PATIENT'S EYESIGHT, SO THE LENS REPLACEMENT IS NOT SCHEDULED. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16500761 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL), UPON EXAMINATION, INCREASED INTRAOCULAR PRESSURE WAS FOUND AT 30 MMHG. THE PATIENT TOOK TABLETS 2 TIMES ORALLY FOR 2 DAYS, AND NORMAL INTRAOCULAR PRESSURE WAS CONFIRMED IN THE FOLLOWING WEEK. THIS IS A STUDY FILE. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 15147863 ↗