Clareon™ CNWTT3 (UDI 00380652468589)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652468589), received between Apr 4, 2023 and Mar 9, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Power Calculation Error” (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.

• MalfunctionMar 9, 2026Device Difficult to Setup or Prepare; Inaccurate Delivery

  A NURSE REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, THERE WAS DIFFICULTY WITH CORRECTLY PLACING THE LENS IN THE CARTRIDGE, AND THEN IN THE INJECTOR, AND THE INTRAOCULAR LENS BECAME STUCK IN THE WOUND AND THE LENS WAS REMOVED IN THE INITIAL PROCEDURE AND REPLACED WITH AN ANOTHER LENS. PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546537 ↗
• InjuryDec 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED WITH AN UNSPECIFIED ISSUE. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT HAD REFRACTIVE LENS EXCHANGE (RLE) FOR THE LEFT EYE (OS). THE PATIENT NEEDED IOL ROTATION AND EXPERIENCED GLARE AND A DARK AREA ON THE PERIPHERY, ALSO NOTICING A DIFFERENCE BETWEEN THE LEFT EYE AND THE RIGHT EYE AFTER SURGERY IN THE RIGHT EYE. THE PATIENT TRIED A CONTACT LENS TRIAL BUT STILL HAD SHADOWS OS. IN THE SURGEON'S OPINION, THE PRODUCT HAD CAUSED OR CONTRIBUTED TO THE EVENT. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL AND DIFFERENT DIOPTER OF THE SAME COMPANY LENS 1 MONTH AND 13 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. THERE WAS NO FURTHER IMPACT TO THE PATIENT, AND THE PATIENT'S ISSUES WERE RESOLVED.

  Patient problems: Visual Disturbances

  MAUDE report 23748086 ↗
• InjuryDec 26, 2023Application Program Problem: Power Calculation Error; Application Program Problem: Power Calculation Error

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED FOR DECREASED VISION AND RIGHT EYE PAIN POST CATARACT SURGERY AND CAME FOR SECOND OPINION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN ANOTHER MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Eye Pain

  MAUDE report 18391849 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED SEVERE GLARE AND HALOS AROUND LIGHTS IN DAY AND NIGHTS .CLINICAL REASON WAS MENTIONED AS UNSATISFACTORY GLARE AND HALOS SIDE EFFECT FROM MULTIFOCAL IOL.THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18384314 ↗
• MalfunctionDec 11, 2023Crack; Crack

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT A CRACK WAS FOUND IN THE OPTIC (NEAR THE ROOT OF TRAILING HAPTIC) AFTER INTRAOCULAR LENS (IOL) WAS IMPLANTED. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT, AND THERE'S NO EFFECT ON THE POSTOPERATIVE VA. THE IOL WAS STILL REMAINS IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299779 ↗
• MalfunctionApr 4, 2023Scratched Material; Scratched Material

  A PURCHASING COORDINATOR REPORTED A SCRATCHED LENS. ADDITIONAL INFORMATION RECEIVED STATED THAT THE SCRATCH WAS NOTICED DURING SURGERY AND THERE WAS PATIENT CONTACT.

  Patient problems: Insufficient Information

  MAUDE report 16672017 ↗