Clareon CNW0T3 (UDI 00380652409711)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652409711), received between Feb 15, 2022 and May 8, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED VISION STILL BLURRY. SUBSEQUENTLY THE LENS WAS REMOVED AND REPLACED WITH AN UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL FAILURE.

  Patient problems: Blurred Vision

  MAUDE report 25128312 ↗
• MalfunctionApr 15, 2026Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION, THE PHYSICIAN NOTICED A SCRATCH ON THE LENS, IT APPEARED ON LENS OPTIC INSIDE, NOT IN FOLDING PROCESS. THE PROCEDURE COMPLETED THE SAME DAY, ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 24884697 ↗
• MalfunctionApr 6, 2026Scratched Material

  A NURSE REPORTED WITH THE DESCRIPTION OF THAT THE OPTICS WERE SCRATCHED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24787886 ↗
• MalfunctionFeb 19, 2026Material Twisted/Bent

  A NURSE REPORTED WITH A DESCRIPTION OF THE INTRAOCULAR LENS (IOL) WAS POSITIONED ON THE POSTERIOR SIDE OF THE LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387084 ↗
• MalfunctionFeb 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INTRAOCULAR LENS OPTIC WAS FOUND BROKEN PARTIALLY IN THE DIRECTION OF 4¿0 CLOCK AND IT WAS IDENTIFIED AFTER IMPLANTATION. THE PROCEDURE WAS COMPLETED WITHOUT USING ANY REPLACEMENT LENS. PHYSICIAN REPORTED THAT BROKEN PART OF THE LENS DID NOT TOUCH THE FORCEPS AND THE PLUNGER. AFTER RE-CHECKING HE FOUND OUT THAT THE OPTIC WAS ALREADY CHIPPED AT THE POINT IT WAS SET INTO THE CARTRIDGE. PHYSICIAN THINKS THAT THE BROKEN IOL DOES NOT AFFECT THE PATIENT'S EYESIGHT. IT WAS REPORTED THAT THERE WAS NO HEALTH HAZARD TO THE PATIENT. THEREFORE, THERE WAS NO MEDICAL TREATMENT GIVEN TO THE PATIENT BUT THE PATIENT IS BEING CLOSELY MONITORED. THE LENS IS STILL IN THE PATIENT EYE AND HENCE THE SAMPLE IS NOT AVAILABLE FOR RETURN. HOWEVER, PHOTOS OF THE IOL ARE AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THE SURGEON SAID THAT ONE OF THE CROSS SECTION OF THE DAMAGED PARTS APPEARED JAGGED, SO PERHAPS THE IOL HAD ALREADY HAD THE DAMAGE AT THE TIME OF SHIPPING. THE SURGEON ALSO STATED THAT THERE IS NO EFFECT ON POSTOPERATIVE VISION.

  Patient problems: Insufficient Information

  MAUDE report 21375518 ↗
• MalfunctionDec 31, 2024Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC TORN OFF. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047305 ↗
• InjuryFeb 15, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS NOTED ON THE IOL. THE SURGERY WAS COMPLETED AFTER REPLACING THE IOL WITH ANOTHER ONE. ADDITIONAL INFORMATION WAS RECEIVED BY THE SAME REPORTER THAT, THERE WAS NO POTENTIAL HEALTH IMPACT TO THE PATIENT. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEM. POSTOPERATIVELY, THE PATIENT HAD NO PROBLEMS. VISUAL ACUITY IS EXPECTED TO IMPROVE AS THE CORNEAL EDEMA DECREASES.

  Patient problems: Corneal Edema

  MAUDE report 13534745 ↗