Clareon CNW0T5 (UDI 00380652410649)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652410649), received between Feb 10, 2022 and Mar 14, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2025Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  A SURGEON REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS TORN BY THE HANDPIECE INJECTOR. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, SURGEON HAD NO ADDITIONAL PLAN FOR TREATMENT AS LENS ONLY HAD MINOR PROBLEM ON THE LENS RIM. THERE WAS NO EFFECT ON PATIENT'S VISION AND THE LENS STILL REMAINS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 21604042 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM. THE SURGEON PLAN TO ROTATE THE POST REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 20890519 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD A POOR EXPERIENCE WITH THE SURGERY. HAS NEVER HAD TO WEAR GLASSES TO SEE TO READ, ONLY WORE GLASSES FOR DISTANCE NEEDS. WOKE UP FROM SURGERY AND WAS VERY UPSET THAT SHE COULD NO LONGER SEE TO READ OR PUT ON MAKEUP. SHE STATES SHE HAS DAILY MIGRAINES AND HER RIGHT EYE WAS PAINFUL. SHE WAS ON STEROID DROPS AND REFRESH DROPS SEVERAL TIMES A DAY. SHE HAS AN APPOINTMENT TO SEE HER SURGEON TOMORROW AND WILL DISCUSS OPTIONS WITH HIM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Eye Pain; Headache

  MAUDE report 20458140 ↗
• InjuryFeb 10, 2022Crack; Crack

  A PHYSICIAN REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND CRACKED THE DAY AFTER SURGERY. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT HARM INVOLVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13503456 ↗