Clareon CNW0T6 (UDI 00380652411196)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652411196), received between Apr 25, 2024 and Jul 11, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS LOADING USING COMPANY CARTRIDGE AND VISCOELASTIC. WHEN THE SURGEON WAS INJECTING THE LENS INTO THE EYE, HE FELT SOME RESISTANCE. ONCE THE IOL WAS IN THE PATIENT'S EYE, SURGEON NOTED THAT THE LENS HAD A CRACK. SURGEON REMOVED THE LENS AND REPLACED WITH ANOTHER LENS. IT WAS STATED THAT THE REASON FOR USING THE COMPANY CARTRIDGE WAS AS IT WAS NOTED ON THE PACKAGING AS THE CARTRIDGE TO USE. PROCEDURE COMPLETED ON THE SAME DAY. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 1 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480850 ↗
• MalfunctionJul 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS LOADING USING COMPANY CARTRIDGE AND VISCOELASTIC. WHEN THE SURGEON WAS INJECTING THE LENS INTO THE EYE, HE FELT SOME RESISTANCE. ONCE THE IOL WAS IN THE PATIENT'S EYE, SURGEON NOTED THAT THE LENS HAD A CRACK. SURGEON REMOVED THE LENS AND REPLACED WITH ANOTHER LENS. AGAIN RESISTANCE WAS FELT AND NOTED THAT THE LENS HAD A CRACK. REMOVED THIS LENS AND REPLACED WITH ANOTHER LENS IT WAS STATED THAT THE REASON FOR USING THE COMPANY CARTRIDGE WAS AS IT WAS NOTED ON THE PACKAGING AS THE CARTRIDGE TO USE. PROCEDURE WAS COMPLETED ON THE SAME DAY. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 2 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480841 ↗
• MalfunctionApr 25, 2024Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn

  A SURGEON REPORTED WITH A DESCRIPTION OF DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS TORN WHEN THE LENS WAS IMPLANTED, CAUSING A CRACK IN THE OPTICAL PART. IT HAS BEEN CONFIRMED THAT THE INJECTOR, CARTRIDGE, AND OVD WERE USED PROPERLY. THE SURGERY HAS NOW BEEN COMPLETED AND THE TORN LENS HAS BEEN IMPLANTED AS IT WAS. THE SURGEON PLANS TO CONSIDER WHETHER TO REPLACE THE PATIENT BASED ON THE POSTOPERATIVE COURSE. THE TORN HAPTIC AND CARTRIDGE WERE RETURNED. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE SURGEON CONSIDERS THAT IT WAS UNLIKELY THAT THE CARTRIDGE WAS A FACTOR.

  Patient problems: Insufficient Information

  MAUDE report 19181150 ↗