Clareon CNWET0 (UDI 00380652405270)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652405270), received between Mar 25, 2025 and May 7, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (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.

• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION IN RIGHT EYE, THE PATIENT EXPERIENCED BLURRED VISION. CONSEQUENTLY, THE LENS WAS REMOVED AND REPLACED WITH AN ANTERIOR CHAMBER INTRAOCULAR LENS (ATIOL) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS RESIDUAL CYLINDER (RESIDUAL ASTIGMATISM) IN THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 25112219 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRY VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 21 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATIONS OF INTRAOCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Blurred Vision

  MAUDE report 24516230 ↗
• MalfunctionOct 24, 2025Material Opacification; Scratched Material; Material Opacification; Scratched Material

  A HEALTH CARE PROFESSIONAL STATED OPTIC SCRATCH AND OPACITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE ENTIRE OPTIC APPEARS CLOUDY, AND THERE WERE NUMEROUS MARKS VISIBLE. SOME OF THE MARKINGS RESEMBLE SCRIBBLES OR SCRATCH-LIKE TRACES.

  Patient problems: Insufficient Information

  MAUDE report 23376428 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED THAT THE VISION IN LEFT WAS CURVY AND WAVY CONSTANTLY. THE PATIENT WAS UNABLE TO DRIVE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATION OF INTRAOCULAR LENS PROSTHESIS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 23366418 ↗
• MalfunctionJul 1, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DAMAGED INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE TRAILING HAPTIC GOT CAUGHT THROUGH THE INJECTOR WITH NO PATIENT CONTACT. THE SURGERY WAS COMPLETED USING BACK UP LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371962 ↗
• InjuryMar 25, 2025Failure to Deliver; Failure to Deliver

  A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE; THE LENS GOT STUCK IN CARTRIDGE. THE PLUNGER PUSHED THE IOL, BUT LENS DID NOT MOVE FORWARD. AN ATTEMPT TO EXTRACT THE IOL FROM THE CARTRIDGE USING VISCOELASTIC WAS ALSO UNSUCCESSFUL. WITH A SIMILAR IOL A SECOND SURGERY WAS PERFORMED FOR IOL IMPLANTATION IN THE APHAKIC EYE WITHOUT ANY HARM TO THE PATIENT. THE PATIENT CONDITION WAS HEALTHY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686357 ↗