Clareon CNW0T4 (UDI 00380652410137)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652410137), received between Jan 28, 2022 and Jul 30, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  A non-health care professional reported that following an intraocular lens (IOL) implantation procedure, the patient's vision was not good. 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 complications.Additional information has been requested but is not available at the time of this report.

  Patient problems: Blurred Vision

  MAUDE report 50086131 ↗
• MalfunctionOct 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF LENS WAS BROKEN OR BENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514476 ↗
• MalfunctionMay 14, 2024Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTING THE LENS INTO THE CAPSULE BAG THE SURGEON NOTICED THAT THE FRONT AND BACK SURFACES OF THE LENS WERE CLOUDY. SHE TRIED TO WASH THE SURFACE OF THE LENS BY IRRIGATION BUT IT DID NOT GIVE ANY RESULT. THE LENS WAS STILL IN THE PATIENT EYE AND THERE WERE NO COMPLICATIONS NOTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT A SECOND INTERVENTION IS NOT YET REQUIRED AND VISUAL ACUITY ON THE FIRST DAY AFTER SURGERY WAS 0.2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308441 ↗
• InjuryOct 13, 2023Malposition of Device; Malposition of Device

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS SEEING BLURRY AND DOUBLE VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED PATIENT WAS HAVING MONOCULAR DOUBLE VISION IN RIGHT EYE, VISION FOGGY, HAD CORNEAL SMOOTHING PROCEDURE IN 2021. SURGEON HAS SAID LENS DISLOCATED/OFF AXIS 20%. SHE HAD DIFFICULTY SEEING AT NIGHT, HAD A LOT OF GLARE. THE PATIENT WAS ABOUT TO SEE CORNEAL SPECIALIST NEXT WEEK.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17929039 ↗
• MalfunctionApr 6, 2023Adverse Event Without Identified Device or Use Problem; Scratched Material; Adverse Event Without Identified Device or Use Problem; Scratched Material

  A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS IOL IMPLANT PROCEDURE, THE SCRATCH WAS FOUND ON THE PERIPHERY OF THE INTRA OCULAR LENS, THAT WAS INSERTED INTO THE EYE. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THE SCRATCH WAS HIDDEN BY THE IRIS, AND THE PATIENT'S POSTOPERATIVE VISION SEEMS TO BE GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16692076 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED ENDOPHTHALMITIS AND THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION RECEIVED STATING ONE-WEEK POST OPERATIVELY THE PATIENT HAD EXPERIENCED CORNEAL EDEMA, ANTERIOR CHAMBER CELLS AND FLARE, FIBRIN AND VITREOUS CLOUDING. AS A RESULT VITRECTOMY AND ANTERIOR CHAMBER WASHOUT WERE PERFORMED AND THE LENS WAS EXPLANTED. THERE WERE NO COMPLICATIONS DURING THE SURGERY. THE PATIENT WAS TREATED WITH UNSPECIFIED STEROIDS, NON-STEROIDS AND ANTIBIOTICS POST-SURGERY. THE EVENT HAS RESOLVED.

  Patient problems: Corneal Clouding/Hazing; Corneal Edema; Endophthalmitis; Inflammation; Uveitis

  MAUDE report 13385363 ↗