Clareon CNWET4 (UDI 00380652466783)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652466783), received between Oct 18, 2023 and Aug 12, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

• MalfunctionAug 12, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222434 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD VERY POOR NEAR AND INTERMEDIATE VISION. HER VISUAL ACUITY (VA) FOR NEAR VISION WAS 20/100, INTERMEDIATE VISION WAS 20/30 AND DISTANCE VISION WAS 20/25. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 2 OF 2.

  Patient problems: Blurred Vision

  MAUDE report 25080370 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT BEGAN EXPERIENCED HAZY VISION IN LEFT EYE (OS) WAS GREATER THAN OD (RIGHT EYE) SO, THE PATIENT UNDERWENT POST PRK (PHOTOREFRACTIVE KERATECTOMY). ADDITIONALLY, THE PATIENT ALSO EXPERIENCING BLURRY VISION AT DISTANCE AND NEAR, HAZY VISION, RESIDUAL ASTIGMATISM, HALOS AND GLARE RESULTING IN AN INABILITY TO DRIVE AT NIGHT. THE PATIENT WAS ADVISED TO CONTINUE USING PRESERVATIVE-FREE ARTIFICIAL TEARS (LUBRICATING EYE DROPS) 3 TO 4 TIMES DAILY. ADDITIONALLY, A TAPERING REGIMEN OF A CORTICOSTEROID WAS INITIATED, WITH INSTRUCTIONS TO INSTILL ONE DROP IN THE LEFT EYE (OS) THREE TIMES A DAY FOR 2 WEEKS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S LEFT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 22095786 ↗
• InjuryOct 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS VERY HAPPY WITH THE VISION OF LENS. THE SURGEON USED BLUE-BLOCKING LENSES WHICH THE PATIENT WAS INTOLERANT. REPORTED THAT THE DAY THE SECOND LENS WAS IMPLANTED FELT VERY SLEEPY ALL THE TIME WHICH CAUSED SLEEP CYCLE ISSUES DUE TO MELATONIN OVERLOAD. THE PATIENT DISCUSSED WITH THE SURGEON BUT COULDN'T FIND THE ANSWER. THE PATIENT DID A LOT OF RESEARCH AND FOUND A SURGEON WHO RECOMMENDED TO EXPLANT THE RIGHT LENS AND EXCHANGE IT FOR A CLEAR LENS. THE SURGEON FEELS IT WILL RESOLVE THE SLEEP CYCLE ISSUE. THE SURGEON HAD ALSO INFORMED THAT HE WILL NOT USE THE BLUE BLOCK LENSES IN THE PATIENT'S EYE BECAUSE OF SCENARIO. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17955112 ↗